Is working in the area of Pharmacovigilance for over 20 years
He has extensive experience of whole life cycle from clinical development till post marketing
Tremendous knowledge when it comes to: Aggregate Reports (PSUR, DSUR, PBRER, PADER), Risk Management, Signal Detection, Project Management and different PV Systems
Pursues a hands-on management style combined with strong communication skills
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Overview
- Availability
- Asap, 5 days/week, on-site & remote
- Qualification
- Masters in biological and medical sciences
- Language Skills
- French (native), English (business fluent)
- Relevant Expertise
- Drug Safety, Aggregate Reports, PV Reports, Clinical Studies, Case Processing, PV Trainings, Risk Management, PV Systems, Signal Detection, Project Management, Pharma, Biotech
Key Facts
Extract from Previous Activities
Pharmaceutical Company, France
Case Medical Safety and Quality Expert
Identify KPIs, Topics & Trends in Case Processing samples
Perform Data analysis
Discuss CAPA and participate in CAPA elaboration (ad hoc)
Lead/present data during Quarterly Oversight Meeting
Monitor CAPA implementation
Management of French Legal cases from the patients
Pharmaceutical Company, France
Drug Safety Officer
Approval and medical assessment of PV reports from both post marketing experience and clinical studies (Immunotherapy)
Prepare aggregate reports within the timelines to Health authorities and Ethics committees of all safety (PV) data (PBRER / PSUR / PADER / DSUR / RMP)
Participation in the maintenance of the quality management system
Drafting and Validation of the SOPs
Regular Signal Detection and evaluation
Weekly Literature screening
PV training to different affiliates around the world
Participation in auditing and CAPA
Participation in CCDS preparation, Provide safety data for CTD submission
Review and drafting of Pharmacovigilance sections of clinical trial documents (study protocols, investigator's brochure, clinical study reports) in collaboration with different departments concerned
Pharmaceutical Company, France
Senior Pharmacovigilance Specialist
Staff management (PV Manager, Budget and Training)
Deputy for EEA QPPV and EVRP for different customers
To Know and be able to interpret/apply relevant technical/scientific guidelines
Provide relevant knowledge in the specific technical/scientific area to the other team members and advise Clients on technical questions
Participate in the writing of deliverables and especially the sections in relation to this specific technical/scientific area
Participate in the in-process and final review of deliverable