Job Summary
A company is looking for a Sr. Pharmacovigilance Risk Management Medical Director.
Key Responsibilities
- Lead the safety strategy for aggregate data on assigned marketed and investigational products
- Develop and maintain strategies for ongoing signal detection and safety profile definition
- Oversee the creation and maintenance of safety information and respond to safety inquiries from regulatory authorities
Required Qualifications, Training, and Education
- M.D. degree required; Board Certification preferred
- Minimum of 8 years of post-residency experience, including 3+ years of clinical experience
- At least 7 years of pharmacovigilance or relevant experience in a pharmaceutical/biotechnology company
- Significant clinical experience may compensate for shorter experience in the pharmaceutical/biotech sector
- Solid knowledge of US and EU pharmacovigilance regulatory requirements
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