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