Associate Marketed Product Safety Director (Deputy QPPV)

About the role

The Associate Marketed Product Safety Director is a fully sponsor-dedicated deputy QPPV (Qualified Person Responsible for Pharmacovigilance) role. The QPPV is a mandatory position for Marketing Authorization Holders operating in the EU, and the deputy receives delegated tasks and can work independently and with authority. Applicants must permanently reside and work in the EU or EEA.

Key responsibilities

• Assist the QPPV in anticipating the impact of emerging regulations on pharmacovigilance processes and product portfolio management, and contribute to regulatory guidance
• Ensure the pharmacovigilance system is properly implemented and that the PSMF accurately reflects it
• Evaluate risks, communicate global impact issues to the QPPV and recommend action plans
• Take part in mandatory client governance meetings and help build the client's reputation at health authority level
• Advise on product-related safety matters affecting the benefit-risk balance, give periodic updates to the QPPV and review or approve documents for regulatory submission

Required profile

• Bachelor's degree in medicine or another healthcare professional degree relevant to the role
• 5 years of experience in a CRO, pharmaceutical or associated industry, or equivalent combination of education, training and experience
• Permanent residence and work in the EU or EEA

Required skills

• Broad pharmacovigilance experience: RMPs, risk minimisation measures, DHPCs, safety variations, PSURs/PBRERs, PSMF, PRAC activities, referrals and product alerts
• Safety profile oversight and signal management, including safety data review and Safety Management Team participation
• Experience interacting with health authorities on safety communications and regulatory activities
• Regulatory affairs across centralised and national procedures
• Cross-functional collaboration, strong judgment, independent decision-making and ability to manage multiple projects

The potential base pay range is EUR 53,000 to EUR 90,200 per year, depending on qualifications, location and schedule; incentives, bonuses and other benefits may also apply.