MSI Pharma are currently working with a mid-sized Global Pharma based in New Jersey to hire a Director level Freelance Safety Physician with experience undertaking benefit and risk analysis activities.
The ideal candidate will have:
- Medical degree
- 5+ years' experience in Drug Safety
- Experience working on Benefit and Risk analysis activities
- Experience working in a Pharma or Biotech company
Main job activities:
- Conducting medical assessments, on-going safety evaluation and signal detection as part of the global Pharmacovigilance organization
- Interacting with EMA, NCAs, Region Europe Affiliates, partners and service providers about safety issues
- Contributing to and reviewing key pharmacovigilance documents such as PADER, DSUR, PBRER/PSURs, CCSIs, Risk Management Plans, safety sections of SmPCs, IBs, Clinical Trial/ Study Protocols, and Final Reports
- Participates in NDA/MAA filings, health authority interactions, and FDA Advisory Committee meetings, as applicable
- Training of company personnel, Contract Research Organisations, and investigational site personnel regarding Pharmacovigilance related issues
KEY WORDS: Pharmacovigilance, Physician, Freelance Job, Benefit:Risk, Drug Safety, PV, Clinical Safety, Clinical Development
