Senior Medical Device Vigilance Scientist
MSI Pharma are working with a specialist business near Paris to hire a Senior Medical Device Vigilance Scientist.
- The primary focus for the role is taking ownership of the post-marketing vigilance activities, in line with industry standards and internal SOPs.
- The successful person may also be involved in clinical safety activities.
- Coordinates and supervises, the design, implementation and maintenance of appropriate vigilance systems including;
- The role holder may also be asked to Act as Local Contact Person for Vigilance
- Project Specific Procedure (PSP),
- Safety Management Plan (SMP);
- Post Market Vigilance Plan
- Individual safety cases management and reporting;
- Integrated and periodic reports: Risk Management Plan (RMP), Periodic Safety Update Report (PSUR)
- Signal detection
- 3+ years of experience in the Pharmacovigilance or Medical device vigilance
- Knowledge of European Vigilance regulations;
- Proven experience in project management
- Knowledge of EU pharmacovigilance regulations
- Experience in a consulting environment or in a CRO is a plus
- Proficiency in French and English;
Keywords; Medical Devices, Vigilance, Risk Management, French, Paris Job,