Description
The Associate Marketed Product Safety Director will serve as a fully sponsor-dedicated deputy QPPV role, supporting the Qualified Person Responsible for Pharmacovigilance (QPPV) in establishing and maintaining the pharmacovigilance system for Marketing Authorization Holders (MAHs) operating in the European Union (EU).
Main Responsibilities:
- Assist the QPPV in analyzing, anticipating, and communicating the impact of emerging regulations on the company's pharmacovigilance processes and product portfolio management for assigned marketed products.
- Contribute to the construction of pharmacovigilance regulatory guidance.
- Advise and guide functions involved to ensure the pharmacovigilance system required by EU regulations is properly implemented.
- Ensure and verify that the information contained in the PSMF is accurate and up-to-date.
- Evaluate risks and communicate global impact issues to the QPPV and recommend action plans.
- Participate in mandatory client governance meetings.
- Assist in developing the client's reputation at health authority level.
Product Portfolio Responsibilities:
- Review and provide advice on product-related safety matters that could impact patient health.
- Provide routine updates on product-related issues to the QPPV.
- Timely review and/or approval of documents intended for submissions to regulatory authorities.
- Other tasks assigned in line with the overall QPPV role.
Requirements:
- At least a Bachelor's Degree in Medicine or another healthcare professional degree with a relevant curriculum.
- 5 years of experience in a Contract Research Organization or Pharmaceutical or associated industry.
- Broad pharmacovigilance experience, including review and contribution to RMPs, DHPC preparation and distribution, safety variations, PSURs/PBRERs, and PRAC-related activities.
- Previous exposure to safety profile oversight and signal management.
- Previous interactions with health authorities, particularly regarding safety communications and risk minimization activities.
- Regulatory affairs experience across both centralized and national procedures.
- Strong cross-functional collaboration and ability to maintain a comprehensive overview of product safety.
- Ability to work on multiple projects and manage competing priorities effectively.
- Strong judgment, independent thinking, decision-making, and problem-solving skills.