8 months ago
Hamlyn Williams is currently working alongside a global pharmaceutical company who well established in the oncology field.
Due to growth, the company is looking to expand with a position for a Safety Physician EU QPPV Office, Associate Director.
In this role, you will function as a safety physician within the EU QPPV office. The contributions of the Associate Director brings the European needs and requirements as well as the European perspective on medical aspects and EU healthcare systems to the global team whilst also acting as a Global Saftey Physician providing medical safety expertise.
Some of the responsibilities include but are not limited to:
- Participating in the conduct of pharmacovigilance for assigned products or projects including medical assessments, on-going safety evaluation, signal detection, determination of the risk management strategy and benefit-risk assessment as part of the global Pharmacovigilance organization.
- Contributing to and reviewing key Pharmacovigilance documents such as PSURs, Risk Management Plans, safety sections of CCDS, SmPCs and other labelling documents, IBs, Clinical Trial/ Study Protocols and Final Reports. Provides expert knowledge to ensure that the documents meet the regulatory requirements.
- Contributing to NDA and MAA filings, health authority interactions, and FDA Advisory Committee meetings, as applicable.
Maintain oversight to ensure compliance of PV system with applicable regulations in the EU.
Act as a contact point to the EU QPPV for all pharmacovigilance matters and safety governance issues, including audits and inspections, for assigned products.
Engage with relevant alliance partners, departments and other key stakeholders to drive continuous improvement to ensure sustained compliance of the PV system with applicable regulations.
This is primarily an office-based role but 2 days working from home can be considered.
If you have any questions or queries, don't hesitate to get in touch!