Medical Device und Pharmacovigilance Manager
Core
Establishing and maintaining the company's pharmacovigilance system while ensuring compliance with medical device regulations, serving as the interface between pharmaceutical and medical device regulatory frameworks.
Role type
Pharmacovigilance and Medical Device Compliance Manager
Builds
Global pharmacovigilance activities, medical device vigilance processes, and regulatory compliance documentation
Domain
Biopharmaceuticals, Rare Diseases, Pharmacovigilance, Medical Device Regulation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmacovigilance system management, EU-GVP compliance, Medical device vigilance processes, Regulatory inspection support, SOP creation and maintenance, Case reconciliation (line listing), Complaint processing and archiving, Safety information reporting and translation, Third-party partner agreement management, CAPA documentation
Preferred skills
MDR/MPBetreibV knowledge, Medical device review, Notified body collaboration
Technologies
Pharmalex, ESPs
Responsibilities
Managing and contributing to all pharmacovigilance activities, Supporting regulatory inspections by national authorities, Performing reconciliation of AE/SAE cases and complaints, Reviewing potential late cases from ESPs, Collecting and reporting drug safety information, Overseeing pharmacovigilance requirements in third-party partner agreements, Acting as person responsible for medical device safety, Monitoring regulatory changes in medical device legislation, Collaborating with external notified bodies and authorities
Seniority
Manager, hands-on IC
