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Local Contact for Pharmacovigilance
hace 2 semanas
Job Overview
Develop and prepare pharmacovigilance agreements for assigned customers. Prepare pharmacovigilance systems master files under direct supervision. Act as deputy EU- QPPV.
- This role will require visits to Health Authorities facilities based on demand, while the rest of the time the role can be performed home-based._
**Essential Functions**
- Availability on a 24/7 basis to receive calls from the local Health Authority as required.
- Act as the contact point for pharmacovigilance inspections.
- Deal directly with the Health Authority inspectors during statutory inspections.
- Ensuring business continuity and in case of absence ensuring back-up/deputy coverage is in place, as required.
- Ensure awareness of relevant functions (e.g. regulatory affairs, clinical, QA) within client affiliate organization and promote pharmacovigilance at local country level.
- Respond fully and promptly to requests from Competent Authorities to evaluate the benefits and risks of a medicinal product to include information regarding sales or prescriptions or post
- authorization of safety studies of medicinal products.
- Verifies that his/her name and contact details have been notified to the Health Authority upon contract commencement. The MAH may wish to inform the Agency or may delegate to the project lead or the LQPPV.
- Remain up to date and aware of any changes in local regulatory requirements; verifies the necessary mechanisms and regulatory measures adopted for safety reasons and the risk management plans are carried out.
- Establish and maintain a thorough understanding of each project’s budget and scope of work (SOW); set up and maintain project materials such as project files, forms, templates, databases and workflow.
- Work in a collaborative team environment with project team members both remotely and on-site; lead by example; assist management with allocating resources to projects. Will be required to work independently within the QPPV role.
- Proactively identify issues and propose solutions. Respond promptly and effectively to all requests.
- Provide regular reports to project manager on project metrics, SOW changes, customer requests or concerns; participate in project review meetings with management; communicate and document project issues to project team members and department management in a timely manner.
- Communicate regular monthly updates to the EU QPPV/designee & complete regulatory reports, as required.
- Liaising and coordinating with the MAH’s European Union Qualified Person for Pharmacovigilance (EU QPPV) in terms of PV tasks and responsibilities. Notify the MAH and/or EU QPPV (where applicable) of emerging signals of safety concerns.
- Communicates signals that may have implications for public health to the Health Authority
- Communicates signals that may have implications to the benefit-risk profile of a product immediately to the HA as an Emerging Safety Issue.
- Maintains awareness of sources and channels for communication of safety information received at country level.
- Ensures that processes and systems are in place to ensure collection and timely reporting of safety data.
- Ensures that processes and systems are in place to ensure the production and timely submission of periodic reports.
- Maintains awareness of local literature journals routinely reviewed and ensures processes are in place to identify and report relevant safety information derived from local journals.
- Ensures awareness of evolving safety profiles of medicines approved in country.
- Ensures awareness and oversight of local risk minimization measures.
- May get involved with collection, translation, recording and follow-up of Individual Case Safety Report(s) (ICSRs) and/or other non-ICSRs safety information relevant to the medicinal product(s) in scope of the project.
- May support the submission of pharmacovigilance reports to authorities including but not limited to Individuals Case Safety Reports, Periodic Safety Update Reports, and Risk Management Plans and Risk Minimization Materials.
- Support the development of corrective and preventive actions as needed.
- Support routine audits and pharmacovigilance inspections.
- Support local compliance interventions as needed and provide recommendations to corrective/preventative action plans associated with inspections, audits or deviations.
- Review and approve risk management plans and periodic safety update reports if required by local regulations.
- Ensures the implementation of risk minimization measures at local level as directed by MAH guidance.
- Maintain an overview of the safety profile of the product and factors that may affect the benefit/risk balance of a product
- Provide review and input to local pharmacovigilance agreements/contracts as needed.
- Manage local pharmacovigilance system master files as needed.
- Ensure pharmacovigilance input to clinical study protocols where necessary.
- Perform other ad-hoc activities as directed.
**Qualifications**
