Manager, Pharmacovigilance and Medical Device Regulations

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

📋 Description

• Establish and continuously enhance the company's pharmacovigilance system.

• Ensure adherence to regulatory standards concerning medical devices.

• Oversee and actively participate in all pharmacovigilance activities.

• Provide support during inspections by national regulatory authorities.

• Develop and maintain pharmacovigilance Standard Operating Procedures (SOPs) and templates.

• Conduct reconciliation of Adverse Event (AE) and Serious Adverse Event (SAE) cases.

• Document and manage deviations related to pharmacovigilance and Corrective and Preventive Actions (CAPAs).

• Serve as the designated individual responsible for the safety of medical devices.

• Monitor changes in regulations pertaining to medical device legislation.

• Collaborate with external notified bodies and regulatory authorities.

⛳️ Requirements

• Completed degree in pharmacy, medicine, natural sciences, or a related field of study.

• 3-5 years of professional experience in the field of pharmacovigilance.

• Comprehensive knowledge of EU Good Pharmacovigilance Practice (EU-GVP) requirements.

• Familiarity with the Medical Device Regulation (MDR)/MPBetreibV and medical device vigilance is a plus.

🏝️ Benefits

• Competitive remuneration for your contributions.

• Focus on maintaining a healthy work/life balance.

• A collaborative and team-oriented work environment.

• Opportunities for professional development and growth.

• Commitment to Diversity and Inclusion.

• Ability to make a positive impact on the lives of patients with ultra-rare diseases in need of life-saving treatments.