Senior Manager Drug Safety

Senior Pharmacovigilance Manager (Post-Marketing Focus)

Location: Munich, Germany (Flexible remote work options available)

We are seeking an experienced Senior Drug Safety Manager to join our dynamic team. In this role, you will be responsible for overseeing pharmacovigilance activities in a post-marketing environment, working with both internal teams and third-party vendors to ensure the highest standards of safety management. The position is based in Munich, with the possibility for partial mobile working.

Key Responsibilities:

• Lead and manage an outsourced pharmacovigilance vendor in a post-marketing setting, including overseeing Signal Management and QPPV services.
• Contribute to and monitor the preparation of post-marketing aggregate reports (PAER, PBRER, PSUR) for the US and EMA regions.
• Organize and support internal Safety Review Committee meetings focused on Signal Management, ensuring timely follow-ups on outcomes.
• Oversee quarterly updates of the Pharmacovigilance System Master File (PSMF).
• Manage and ensure timely registration updates for XEVMPD.
• Supervise and maintain the EMA/EVweb accounts and manage the registration of the company and vendor personnel.
• Ensure high-quality processing of Individual Case Safety Reports (ICSRs) and Serious Adverse Events (SAEs) through vendor oversight, ensuring compliance with KPIs and quality review standards.
• Maintain cost control and on-time completion of outsourced pharmacovigilance activities.
• Drive collaboration with external partners to ensure quality safety reporting.
• Ensure adherence to SOPs, Good Clinical Practice (GCP), Good Pharmacovigilance Practices (GVP), and relevant regulatory requirements.

Qualifications & Skills:

• A minimum of 4 years of relevant experience in the pharmaceutical or biopharmaceutical industry, with at least 2-3 years in post-marketing pharmacovigilance.
• In-depth understanding of safety reporting and the regulatory environment for pharmacovigilance in the US and EMA post-marketing settings.
• Strong ability to collaborate effectively with international, cross-functional teams and external partners.
• Proven organizational skills and the ability to manage multiple projects simultaneously.
• Proficiency in written and spoken business English; German language skills are a plus.