Job Description

PrimeVigilance is looking for a Medical Information Associateto be responsible for supporting the Medical Information team in handling initial adverse event and medical information inquiries in English.  

Responsibilities 

• To provide approved responses to medical enquiries (healthcare professionals, patients, pharmaceutical clients) including call handling  

• To accurately identify, document and report adverse events/side effects, pregnancy and other special situation events, and product quality complaints within required timeframes 

• To ensure that all medical information enquiries are tracked and fully documented within the Medical Information database accurately and completely 

• To participate in the out-of-hours provision of medical information for clients who have contracted a 24/7 enquiry handling service 

 • Providing management with regular updates regarding project status and metrics concerning enquiries 

• Assisting in departmental regulatory inspection preparedness for the company pharmacovigilance system and actively participating in PV inspections or audits;  

Qualifications

• Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, pharmacy, nursing) 

• Customer service or call centre experience preferred 

• Comfortable receiving enquires by phone

• Ability to perform out-of-hours service if required 

• Time and issue management, delegation, organization and multitasking skills with good attention to detail 

• Strong interpersonal and communication skills 

• Advanced English skills, both verbal and written

See more jobs at Ergomed

Apply for this job

Job Description

• Assures and exerts activities leading to effective cooperation with clients in the area of ICSR Management
• Contributes to achieving company´s goals and objectives
• Works under supervision of more experienced colleague
• Providing support to other activities undertaken by the project team on behalf of the client and the company
• Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to):
• Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
• Performing ICSR follow up
• SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
•  Reconciliation (clinical, partners)
• Product Quality Complaint handling and interaction with Quality Assurance
• Medical Information interaction
• Database Outputs and Reports (including data for monthly reporting to clients)

Qualifications

We expect:

• Experience in Pharmacovigilance Case Processing
• Fluency in English 
• Good IT skills (MS Office)
• Excellent organization skills with attention to detail
• Excellent interpersonal and communication skills

See more jobs at Ergomed

Apply for this job

Job Description

Due to growth Ergomed is recruiting for an experience CRO Business Development Director in the Southeast, USA..

Duties and responsibilities

• Initiates, coordinates and develops strategic plans and sales strategies within a specified territory or accounts.
• Develop account strategies & implementation plans and expand through accounts
• Identify new markets and research new business opportunities, identifies likely sales points within a specified territory or accounts
• Collect critical information for proposal preparation and provide detailed input and leadership of the proposal process for each opportunity initiated
• Prepare and organize sponsor presentations
• Facilitate the preparedness of the team in attending any client meetings. For example, Capabilities meetings or Bid Defence Meetings (BDM)
• Coordinate and monitor any budget or contract negotiations, post award of any work, within a specified territory or accounts.
• Interact with operations, keeping track of study status for projects with sponsors and help coordinate change orders when notified of a change of scope by operations.
• Establish and maintain regular contact and an excellent rapport with future and current clients.
• Monitor and track competitor CRO activities
• Plan and attend major industrial events and tradeshows 

Qualifications

• Considerable CRO sales experience with strong negotiation and analytical skills
• An established network of decision makers within Pharmaceutical and Biotechnology companies and a proven track record of identifying and securing profitable service contracts.
• Awareness of trends and government policies and regulations in the clinical trials area of Ergomed Group countries
• Excellent communication skills and team leadership capabilities consistent with influencing and driving multiple stakeholders towards meeting the customer’s needs.
• Strong and effective presentation skills; ability to convincingly present features and benefits of service to clients
• Excellent organisational, planning and multitasking skills, as well as a predisposition to entrepreneurship, results and customer focus
• Ability to travel according to the needs of the business development strategy 

See more jobs at Ergomed

Apply for this job

Job Description

Due to growth Ergomed is recruiting for an experience CRO Business Development Director.

Duties and responsibilities

• Initiates, coordinates and develops strategic plans and sales strategies within a specified territory or accounts.
• Develop account strategies & implementation plans and expand through accounts
• Identify new markets and research new business opportunities, identifies likely sales points within a specified territory or accounts
• Collect critical information for proposal preparation and provide detailed input and leadership of the proposal process for each opportunity initiated
• Prepare and organize sponsor presentations
• Facilitate the preparedness of the team in attending any client meetings. For example, Capabilities meetings or Bid Defence Meetings (BDM)
• Coordinate and monitor any budget or contract negotiations, post award of any work, within a specified territory or accounts.
• Interact with operations, keeping track of study status for projects with sponsors and help coordinate change orders when notified of a change of scope by operations.
• Establish and maintain regular contact and an excellent rapport with future and current clients.
• Monitor and track competitor CRO activities
• Plan and attend major industrial events and tradeshows 

Qualifications

• Considerable CRO sales experience with strong negotiation and analytical skills
• An established network of decision makers within Pharmaceutical and Biotechnology companies and a proven track record of identifying and securing profitable service contracts.
• Awareness of trends and government policies and regulations in the clinical trials area of Ergomed Group countries
• Excellent communication skills and team leadership capabilities consistent with influencing and driving multiple stakeholders towards meeting the customer’s needs.
• Strong and effective presentation skills; ability to convincingly present features and benefits of service to clients
• Excellent organisational, planning and multitasking skills, as well as a predisposition to entrepreneurship, results and customer focus
• Ability to travel according to the needs of the business development strategy 

See more jobs at Ergomed

Apply for this job

Job Description

The position is primarily responsible for the creation, maintenance and review of client Pharmacovigilance System Master Files, in line with global regulations, legislation, PrimeVigilance and Client requirements.

The position will maintain and manage PSMF for clients, activities will include PSMF:

• Authoring
• Revision
• Quality check review
• Tracking
• Attend regular PSMF meetings with internal employees and Clients.
• Fulfilment of tasks assigned by the Line Manager.
• Provision of training in PSMF area.
• Revision and update of PSMF related quality documents.

Qualifications

• Degree qualification preferred, ideally in life sciences - pharmacy, nursing or other healthcare related qualification
• Some experience/knowledge of Pharmacovigilance is required.
• Organisational skills, including attention to detail and multi tasking.
• Management skills, including time and issue management
• Excellent communication skills  

See more jobs at Ergomed

Apply for this job

Job Description

The Manager, Project Finance is responsible for managing a team of project financial analysts to provide financial and analytical support to the Department Heads and Project Management teams through performance reporting and financial analysis. The Manager will serve as the liaison between Primevigilance's functional groups and Finance, making recommendations for process and profit improvement.

Line management of up to 15 reports based in Croatia is expected.

Qualifications

• Bachelor’s in Finance, Accounting or equivalent education and experience.
• Demonstrated management experience , preferably in project analysis.
• Extensive relevant finance management or accounting experience, project accounting/analysis a plus.
• Pharmaceutical or CRO experience is desirable.

See more jobs at Ergomed

Apply for this job

Job Description

The PV Project Manager will be responsible for leading and managing long term engagements with our clients.

• Acting as the primary contact point for project-related matters for both the client and PrimeVigilance staff.
• Project activities planning.
• Coordinating the colleagues working on a project.
• Assurance of training of all team members from relevant quality documents, including project-specific documentation.
• Having an overview of all tasks to be delivered to the client, including deadlines and interim milestones.
• Making sure that all the outputs are delivered in high quality and before the final deadline set up by client.
• Reporting the client and the PrimeVigilance management, e.g., preparation of Monthly reports, serving as basis for invoicing.
• Preparation of Accounting of Services and invoice, if delegated.

Qualifications

• Health Care Professional or Life Science Graduate 
• Proven track record of demonstrated Pharmacovigilance activities including processing and quality review of ICSRs, writing, or contributing to aggregate reports, literature screening, reconciliation, and preparation of SOPs 
• PV Project Management experience from ideally a service provide / CRO
• Be comfortable with communicating at senior levels within pharmaceutical organizations 
• Have good leadership qualities including skills in planning, mentoring, meeting facilitation, communication and problem solving. 

See more jobs at Ergomed

Apply for this job

Job Description

Responsibilities include:

• To review and approve post-marketing Individual Case Safety Reports (lCSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. Review includes coding, assessment of seriousness, listedness / expectedness and Company causality, as well as writing of Company comment, follow-up questions and Analysis of Similar Events, when required. Including completion of all required supporting documentation such as trackers.
• To review literature screening search strategy
• To review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings
• Reviewing database outputs
• To review and provide input in Periodic Safety Update Reports
• To review and provide input in Development Safety Update Reports
• Participating in signal detection activities including meetings and writing signal detection reports
• Proposing a course of action whenever a possible signal is identified

Qualifications

• Medically qualified as a physician with demonstrated experience in Pharmacovigilance
• Any experience in aggregate reports and signal detection is desirable
• Excellent interpersonal skills
• Ability to plan, organise, prioritise and execute multiple tasks
• Ability to work effectively cross culturally and cross functionally and value the importance of teamwork
• Communication skills
• Presentation skills

See more jobs at Ergomed

Apply for this job

Job Description

Responsibilities include:

• To review and approve post-marketing Individual Case Safety Reports (lCSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. Review includes coding, assessment of seriousness, listedness / expectedness and Company causality, as well as writing of Company comment, follow-up questions and Analysis of Similar Events, when required. Including completion of all required supporting documentation such as trackers.
• To review literature screening search strategy
• To review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings
• Reviewing database outputs
• To review and provide input in Periodic Safety Update Reports
• To review and provide input in Development Safety Update Reports
• Participating in signal detection activities including meetings and writing signal detection reports
• Proposing a course of action whenever a possible signal is identified

Qualifications

• Medically qualified as a physician with demonstrated experience in Pharmacovigilance
• Any experience in aggregate reports and signal detection is desirable
• Excellent interpersonal skills
• Ability to plan, organise, prioritise and execute multiple tasks
• Ability to work effectively cross culturally and cross functionally and value the importance of teamwork
• Communication skills
• Presentation skills

See more jobs at Ergomed

Apply for this job

Job Description

The Senior Director / Executive Director, Operational Strategy - Oncology (SDOS / EDOS) will be responsible for developing effective Win Strategies in the pre-award period for new business opportunities in oncology and oncology-related indications.

Upon award, the SDOS / EDOS will ensure overall operational excellence by assisting in the transition of operational strategy to operational execution. 

The SDOS / EDOS will also have responsibility for ensuring that the other operational strategists that support oncology remain abreast of oncology research and treatment trends, guidelines and regulations.

The SDOS / EDOS requires extensive clinical trial operations,  execution and strategy experience to support operational design solutions, budget reviews and project oversight.

Role and Responsibilities

• Responsible to coordinate and develop competitive and flexible Win Strategies for potential awards in oncology and oncology-related indications, leveraging expertise, operational capabilities, and technologies to ensure client needs are addressed in the pre-award activities. This includes reviewing project budgets and supporting the Executive Bid Review process.
• Serves as the lead oncology strategist for potential awards.
• Co-leads bid defense preparations with Business Development and participates in other client meetings. 
• Develops strong relations with clients’ key decision makers to drive repeat business.
• Collaborates closely with other global functions, such as Project Management, Clinical Operations, Data Management, Statistics, Regulatory and Safety to enhance client relations and ensure high customer satisfaction.
• Provides therapeutic and technical expertise as part of study transition and thereafter as requested or as part of governance.
• Remains current regarding the regulatory environment as it impacts the oncology and oncology-related portfolio.
• Stays abreast of the development of new, competitive, operational methodologies in oncology and provides training to operational strategists, operational leadership and business development, when appropriate.
• In the capacity of as a stakeholder in the project governance process, provides proactive guidance and direction to assigned staff around project planning, project execution, project review, risk mitigation, problem solving and customer management to assist in service delivery and professional development.
• Supports business development and marketing activities by participating in conferences and meetings and generates marketing content such as webinars and white papers, as part of Ergomed Group’s overall marketing strategy.
• Participates actively in executive Project Review Meetings if requested and supports any changes in strategy that may be necessary as the scope of the study evolves.

Qualifications

• Degree in a life science or another related field, or equivalent education and experience.

• Demonstrated leadership experience from a CRO providing strategy, project oversight and delivery in oncology

• Proven track-record in maintaining, developing and strengthening customer relations

• Strong knowldge of oncology clinical trial design

• Ability to manage multiple project portfolios in an entrepreneurial environment.

• Proven organizational, planning and multitasking skills, as well as a predisposition to customer value and results (e.g., new business wins, repeat business, etc.).

• Ability to interact with internal and external clients at all levels while displaying the highest degree of professionalism.

• Experience in developing project budgets that align the work effort associated with the Win Strategy while targeting gross margins 

See more jobs at Ergomed

Apply for this job

Job Description

As the (Senior) Vice President, Enterprise Architecture and Transformation, you will play a crucial leadership role within our organization, taking on the responsibility of overseeing and managing the global technology architecture across all of Ergomed. You will report directly to the Chief Technology Officer (CTO) and be focused on driving innovation, optimizing our technology landscape, delivering measurable business value through your efforts and partnering with business teams to achieve technology-focused top line and bottom line business and IT transformation.

Key Responsibilities:

• Partner with business and technology leadership to identify opportunities for change, develop business cases, prioritize and select opportunities and achieve dynamic change.
• Partner with teams to ensure business and IT objectives and relationships remain aligned and focused on Ergomed targets.
• Craft and execute an overall architecture strategy, ensuring it supports the company's strategic goals and business line tactical goals.
• Collaborate with senior leadership across technology and product development to influence strategic decision-making, ensuring architectural strategies are integrated with business objectives.
• Oversee a diverse technology landscape, bringing together in-house developed software and third party applications to create a cohesive ecosystem.
• Identify opportunities to grow our existing product suite and develop new product opportunities by aligning with technology partners and applicable client teams.
• Ensure our architecture remains agile and scalable, facilitating quick adaptation to market changes and new opportunities.  Ensure out product suite adheres to the same.
• Engage with the software engineering community to uphold engineering excellence, ensuring the appropriate definition and use of standards, patterns, and the evolution of tools.
• Identify and analyse regulatory and business trends impacting our tech stack and work with partners to remediate and gain competitive advantage if possible.
• You will take a hands-on approach to the design, development, and deployment of architecture frameworks, ensuring that (with business leadership) business value and return on investment (ROI) are delivered in a timely manner per agreed upon targets.
• Quantify technology investment against business ROI targets.
• You will stay up-to-date with the latest advancements in enterprise architecture and healthcare technology, driving the adoption of best practices and industry standards to maintain our competitive edge and deliver cutting-edge solutions.
• Participate with applicable teams to identify M&A opportunities, target value and/or differentiators and achieve business development and functional team goals.

Qualifications

Required Qualifications:

• You should have extensive experience in architecture, with considerable experience in a leadership role, and a proven track record of delivering business value through architectural initiatives.
• You should have a proven track record of successfully delivering enterprise architecture projects in life sciences, with demonstrable ROI and business value.
• You must possess excellent communication, leadership, and stakeholder management skills, with the ability to articulate the business value of architectural initiatives to both technical and non-technical audiences.
• You should be able to work in a fast-paced, collaborative environment and adapt to changing priorities, while maintaining a focus on delivering business value.

Preferred Qualifications:

• Domain knowledge in pharmacovigilance, clinical trials, or healthcare operations, and an understanding of how architecture can drive business value in these areas, is highly desirable.
• Experience with cloud computing platforms, such as Azure, AWS or Google Cloud, and the ability to leverage these platforms to deliver scalable and cost-effective architectural solutions, would be a significant advantage.
• Familiarity with healthcare data standards, such as HL7, FHIR, and SNOMED CT, and the ability to leverage these standards to drive interoperability and data quality, would be beneficial.
• Knowledge of regulatory requirements for IT in healthcare, such as GDPR, HIPAA, and FDA guidelines, and the ability to ensure compliance while delivering business value, would be a plus.
• Familiarity with the software development lifecycle (SDLC) and software development within a GxP framework.

We offer a competitive salary, comprehensive benefits package, and the opportunity to work with a talented and dedicated team at the forefront of architectural innovation in the healthcare industry. If you are passionate about leveraging architecture to improve operational efficiency, patient outcomes, and healthcare costs, we would love to hear from you and discuss how you can contribute to our mission.

See more jobs at Ergomed

Apply for this job

Job Description

This is an exciting opportuniy for a freelancer / consultant to join our team as Local Contact Person for Pharmacovigilance and Regulatory Affairs at 0.5 FTE.

By working with us, you will have the opportunity to work in an international team and strength your expertise within the broad and diverse PV and Regulatory Affairs area.

Main responsibilities

• Primary contact person for local regulatory authority / Pharmacovigilance expert as per local requirements
• Prompt and effective communication with local regulatory authorities
• Provision of local regulatory intelligence screening and expert advice
• Collection and reporting of locally suspected ADRs or ICSRs (FUs, translations)
• Local management / oversight of risk minimization measures related to urgent safety restrictions and emerging safety issues
• Review and linguistic input on local Product Information and Mock-ups  
• Perform local non-indexed literature screening and screening of Regulatory Authority website/s for potential Adverse Drug Reactions (ADRs) and safety information
• Support audits and Inspections
• Handle local QA tasks such as suspected falsified products, quality alerts received from HA) and other quality-related requirements received from the local market

Qualifications

• Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent experience
• Demonstrated experience within pharmaceutical or CRO industry or Regulatory body
• Must have experience within LCPPV / LCPRA roles
• PV training and/or working experience and other educational or professional background as required locally
• Expert knowledge of ICH GVP and most relevant legislation/ local requirements for territories of competency
• Proficiency in English, both written and verbal and in local language
• Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint
• Must currently be set up to work as a freelancer / consultant

See more jobs at Ergomed

Apply for this job

Job Description

The position is primarily responsible for the creation, maintenance and review of client Pharmacovigilance System Master Files, in line with global regulations, legislation, PrimeVigilance and Client requirements.

The position will maintain and manage PSMF for clients, activities will include PSMF:

• Authoring
• Revision
• Quality check review
• Tracking
• Attend regular PSMF meetings with internal employees and Clients.
• Fulfilment of tasks assigned by the Line Manager.
• Provision of training in PSMF area.
• Revision and update of PSMF related quality documents.

Qualifications

• Degree qualification preferred, ideally in life sciences - pharmacy, nursing or other healthcare related qualification
• Some experience/knowledge of Pharmacovigilance is required.
• Organisational skills, including attention to detail and multi tasking.
• Management skills, including time and issue management
• Excellent communication skills  

See more jobs at Ergomed

Apply for this job

Job Description

POSITION SUMMARY: Manages ICSR Management Unit for assigned staff and ensures all unit-relevant activities are delivered within agreed extent. Contributes to achieving company´s goals and objectives. Performs project budget reviews, and provides support to, and management of, the ICSR leads. Other responsibilities include independent analysis of workload, productivity and utilization of resources and their appropriate redistribution to ensure performance of the highest quality as well as coordination with other departments for all activities related to the ICSR Management Unit.

Role and Responsibilities:

• Managing the assigned ICSR Management Unit effectively
• Ensuring adequate resources within the ICSR project teams to achieve the maximum level of productivity and utilisation
• Setting productivity targets for ongoing projects and reviewing proposed target updates as required
• Based on reports and analyses, defining the appropriate reallocation of resources in ICSR Management Unit, or working with the resourcing unit for reallocation to and from other units and departments
• Managing ICSR Leads/Line Managers to ensure all employees are adequately utilised and productive and reallocating employees to other ICSR Leads/teams as necessary
• Notifying the Resourcing department about the need for additional resources for assigned project teams if resources cannot be managed internally and officially opening the requests upon approval and budget confirmations
• Proposing the necessary changes within the project team processes to ICSR leadership
• Finding solutions and introducing best practices to increase productivity and utilization within the ICSR Management Unit
• Training and mentoring of ICSR Line Managers and senior staff.
• Preparing various analyses and reports
• Reviewing budgets and resource allocations for all new projects and new scope of work for existing projects and supporting Directors of Projects, as applicable
• Supporting the Business/Commercial team during development of contracts and proposals, as applicable
• Supporting the Operations and Project Analytics team, as applicable
• Assisting HR in employee recruitment, performance evaluation, promotion, retention and termination activities
• Reviewing and approving all Critical CAPAs from the ICSR Management Unit
• Reviewing and addressing any requests from Quality department regarding ICSR Management Unit
• Reviewing and updating PrimeVigilance operating procedures and guidelines, as applicable
• Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager

Qualifications

Education, qualifications and professional memberships: Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance - Intermediate.

EXPERIENCE: 6-7 years of work experience in pharmacovigilance within which 2-3 years of work experience in line manager role - Advanced.

SPECIAL SKILLS (Advanced): 

• Excellent communication (written and verbal) skills
• Excellent organization skills, including attention to details and multitasking
• Excellent management skills, including delegation skills, time and issue management
• Technical skills
• Team working

LANGUAGE SKILLS: English – fluent (spoken, written) -  Full Professional;

PC SKILLS: Advanced literacy (MS Office) - Advanced:

See more jobs at Ergomed

Apply for this job

Job Description

The PV Associate should be a Life science / bio medical background graduate or have other healthcare related degree qualification (chemistry, biology, biotechnology, veterinary science etc.) This is an opportunity for new graduates to start and develop their career within drug safety. The PV Associate will be working as part of a project team, performing and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance.  

If you join PrimeVigilance, you can expect to work with teams of different sizes, from small clinical trial, to large, generic post-marketing teams. We are always looking for proactive, capable and motivated individuals who aim to surpass any target set in front of them 

Responsibilities: 

• Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines, focusing on triage, data entry, quality review and submissions workflow steps. 
• Reconciliation activities for all types of received reports 
• Works under supervision and mentoring of more experienced colleague 

Qualifications

Requirements: 

• Advanced English and German skills, both verbal and written, at least B2 
• Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science), previous experience is not required. 
• People who are excited to learn and contribute to patient safety 
• Time and issue management, delegation, organization and multitasking skills with good attention to detail 
• Strong interpersonal and communication skills 

See more jobs at Ergomed

Apply for this job

Job Description

Due to growth Ergomed is recruiting for an experience CRO Business Development Dircetor.

Duties and responsibilities

• Initiates, coordinates and develops strategic plans and sales strategies within a specified territory or accounts.
• Develop account strategies & implementation plans and expand through accounts
• Identify new markets and research new business opportunities, identifies likely sales points within a specified territory or accounts
• Collect critical information for proposal preparation and provide detailed input and leadership of the proposal process for each opportunity initiated
• Prepare and organize sponsor presentations
• Facilitate the preparedness of the team in attending any client meetings. For example, Capabilities meetings or Bid Defence Meetings (BDM)
• Coordinate and monitor any budget or contract negotiations, post award of any work, within a specified territory or accounts.
• Interact with operations, keeping track of study status for projects with sponsors and help coordinate change orders when notified of a change of scope by operations.
• Establish and maintain regular contact and an excellent rapport with future and current clients.
• Monitor and track competitor CRO activities
• Plan and attend major industrial events and tradeshows 

Qualifications

• Considerable CRO sales experience with strong negotiation and analytical skills
• An established network of decision makers within Pharmaceutical and Biotechnology companies and a proven track record of identifying and securing profitable service contracts.
• Awareness of trends and government policies and regulations in the clinical trials area of Ergomed Group countries
• Excellent communication skills and team leadership capabilities consistent with influencing and driving multiple stakeholders towards meeting the customer’s needs.
• Strong and effective presentation skills; ability to convincingly present features and benefits of service to clients
• Excellent organisational, planning and multitasking skills, as well as a predisposition to entrepreneurship, results and customer focus
• Ability to travel according to the needs of the business development strategy 

See more jobs at Ergomed

Apply for this job

Job Description

The PV Project Manager will be responsible for leading and managing long term engagements with our clients.

• Acting as the primary contact point for project-related matters for both the client and PrimeVigilance staff.
• Project activities planning.
• Coordinating the colleagues working on a project.
• Assurance of training of all team members from relevant quality documents, including project-specific documentation.
• Having an overview of all tasks to be delivered to the client, including deadlines and interim milestones.
• Making sure that all the outputs are delivered in high quality and before the final deadline set up by client.
• Reporting the client and the PrimeVigilance management, e.g., preparation of Monthly reports, serving as basis for invoicing.
• Preparation of Accounting of Services and invoice, if delegated.

Qualifications

• Health Care Professional or Life Science Graduate 
• Proven track record of demonstrated Pharmacovigilance activities including processing and quality review of ICSRs, writing, or contributing to aggregate reports, literature screening, reconciliation, and preparation of SOPs 
• PV Project Management experience from ideally a service provide / CRO
• Be comfortable with communicating at senior levels within pharmaceutical organizations 
• Have good leadership qualities including skills in planning, mentoring, meeting facilitation, communication and problem solving. 

See more jobs at Ergomed

Apply for this job

Job Description

This is an exciting opportuniy for a freelancer / consultant to join our team as Local Contact Person for Pharmacovigilance and Regulatory Affairs at 0.5 FTE.

By working with us, you will have the opportunity to work in an international team and strength your expertise within the broad and diverse PV and Regulatory Affairs area.

Main responsibilities

• Primary contact person for local regulatory authority / Pharmacovigilance expert as per local requirements
• Prompt and effective communication with local regulatory authorities
• Provision of local regulatory intelligence screening and expert advice
• Collection and reporting of locally suspected ADRs or ICSRs (FUs, translations)
• Local management / oversight of risk minimization measures related to urgent safety restrictions and emerging safety issues
• Review and linguistic input on local Product Information and Mock-ups  
• Perform local non-indexed literature screening and screening of Regulatory Authority website/s for potential Adverse Drug Reactions (ADRs) and safety information
• Support audits and Inspections
• Handle local QA tasks such as suspected falsified products, quality alerts received from HA) and other quality-related requirements received from the local market

Qualifications

• Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent experience
• Demonstrated experience within pharmaceutical or CRO industry or Regulatory body
• Must have experience within LCPPV / LCPRA roles
• PV training and/or working experience and other educational or professional background as required locally
• Expert knowledge of ICH GVP and most relevant legislation/ local requirements for territories of competency
• Proficiency in English, both written and verbal and in local language
• Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint
• Must currently be set up to work as a freelancer / consultant

See more jobs at Ergomed

Apply for this job

Job Description

The PrimeVigilance Medical Writer II/III position offers a unique opportunity to further develop your career in the field of drug safety.

Key Responsibilities

• Independent authoring, editing and reviewing of various regulatory/clinical documents (e.g. aggregate reports, risk management plans and other documents needed throughout the product’s life cycle) with the responsibility for the quality and content of the document and compliance with internal and external standards
• Active participation in trainings and development, implementation and maintenance of quality system documents for medical writing, including internal templates and formats required for standardised documentation
• Support in all pharmacovigilance operations associated with medical writing
• Continuous self-education in all aspects associated with medical writing

Qualifications

• Previous experience of pharmacovigilance medical writing, including PBRERs, DSURs, RMPs writing
• pharmacist or MD, life science MD
• Ability to manage multiple and varied tasks and prioritize workload with attention to detail
• Ability to effectively train and mentor Associate Medical Writers
• Advanced knowledge of English

See more jobs at Ergomed

Apply for this job

Job Description

The PrimeVigilance Medical Writer II/III position offers a unique opportunity to further develop your career in the field of drug safety.

Key Responsibilities

• Independent authoring, editing and reviewing of various regulatory/clinical documents (e.g. aggregate reports, risk management plans and other documents needed throughout the product’s life cycle) with the responsibility for the quality and content of the document and compliance with internal and external standards
• Active participation in trainings and development, implementation and maintenance of quality system documents for medical writing, including internal templates and formats required for standardised documentation
• Support in all pharmacovigilance operations associated with medical writing
• Continuous self-education in all aspects associated with medical writing

Qualifications

• Previous experience of pharmacovigilance medical writing, including PBRERs, DSURs, RMPs writing
• pharmacist or MD, life science MD
• Ability to manage multiple and varied tasks and prioritize workload with attention to detail
• Ability to effectively train and mentor Associate Medical Writers
• Advanced knowledge of English

See more jobs at Ergomed

Apply for this job