Location: Remote, CT Fully remote and onsite required during Inspections
Shift hours: 8am to 4pm or 9am to 5pm Mon-Fri
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Hours Per Day: 10.00
Days Per Week: 40.00
Education and Experience Requirements
- Bachelorโs degree (advanced degree preferred) in life science or healthcare (e.g. nursing, pharmacy)
- Minimum 5 years of experience in a pharmaceutical/biopharmaceutical company
- Minimum 3ย years in Drug Safety Operations role;
- Experience overseeing CRO teams of case processors preferred
- US FDA pharmacovigilance inspection experience preferred
Necessary Knowledge, Skills, and Abilities
- Resource and workflow management (monitoring and assigning tasks)
- Up-to-date knowledge of US and international PV regulations and best practices
- MedDRA coding
- Considers present and future impacts when making recommendations
- Strong negotiationย and problem-solving skills
- Analytical skills and attention to detail
- Accountability โ takes ownership of deliverables