W2 Contract Safety Physician - California/Remote within PST timezone
MSI Pharma are currently working with a Global Pharma based in California 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
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Freelance Safety Physician - California
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Location:
California
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Sector:
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Contact:
Edward Jessel
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Salary:
Negotiable
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Job type:
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Contact email:
pharmajobs@msigroupltd.com
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Job ref:
VR/03665_1613989794
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Published:
about 3 years ago
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Duration:
6 months
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Startdate:
ASAP