Public summary
Join a global biopharmaceutical company focused on innovative therapies for rare diseases. This role in Germany involves leading pharmacovigilance activities and ensuring compliance with medical device regulations. You will manage safety systems, support regulatory inspections, maintain SOPs, and act as the liaison between pharmaceutical and medical device regulatory requirements. Competitive compensation and work/life balance are emphasized in a collaborative and diverse environment.
Location and work setup
- Location
- Munich
- Remote status
- On-site
- German requirement signal
- Unclear
- Detected job language
- English
Responsibilities
Establish, maintain, and improve the company's pharmacovigilance system; manage all pharmacovigilance activities including adverse event processing and reporting; support national and global regulatory inspections; develop and update SOPs and training materials; oversee pharmacovigilance compliance and deviations; act as responsible person for medical device safety under MPBetreibV; ensure medical device vigilance and regulatory compliance with MDR; collaborate with notified bodies and authorities; monitor regulatory changes and maintain documentation.
Qualifications
Completed degree in pharmacy, medicine, natural sciences, or comparable field; 3-5 years professional experience in pharmacovigilance; strong knowledge of EU Good Pharmacovigilance Practice (EU-GVP); familiarity with MDR and MPBetreibV and medical device vigilance is advantageous; ability to coordinate cross-functional regulatory requirements and training.