Medical Device, Pharmacovigilance Manager

This is a fully remote position, open to applicants in Germany.

📋 Description

• Developing, maintaining, and continuously enhancing the company's pharmacovigilance framework.

• Ensuring adherence to regulatory standards for medical devices.

• Overseeing and participating in all pharmacovigilance (PV) operations.

• Assisting with inspections conducted by national regulatory bodies.

• Creating and updating PV standard operating procedures (SOPs) and templates.

• Providing training to colleagues on pharmacovigilance practices.

• Recording and managing deviations and corrective actions related to PV.

• Serving as the designated individual responsible for medical device safety in line with regulations.

• Collaborating with external notified bodies and regulatory authorities as necessary.

⛳️ Requirements

• A completed degree in pharmacy, medicine, natural sciences, or a related field.

• 3-5 years of relevant professional experience in pharmacovigilance.

• Comprehensive understanding of EU Good Pharmacovigilance Practice (EU-GVP) guidelines.

• Familiarity with the MDR/MPBetreibV and medical device vigilance is a plus.

🏝️ Benefits

• Competitive compensation for your contributions.

• Focus on maintaining a work/life balance.

• A collaborative and team-oriented workplace culture.

• Opportunities for professional development and growth.

• Commitment to diversity and inclusion.

• Contributing to making a positive impact for patients with ultra-rare diseases in need of life-saving treatments.