Sr. Director, Pharmacovigilance/ Drug Safety
Brio Resource GroupRaleigh, North Carolina, United States • Colorado, United States
Posted June 24, 2020
Full Time
About the Company
Brio Resource Group is a search firm committed to providing rare pharmaceutical talent on an executive search basis to the Pharmaceutical, Biopharma, Device and CRO industries.
Job Description
Brio Resource Group is seeking a highly qualified Sr. Director, Pharmacovigilance/ Drug Safety for a permanent position with our client, a medical device company. The ideal candidate would be a team player who is extremely detail oriented looking to join a company that is rapidly changing the healthcare industry.
Requirements
- Support the Drug Safety Department
- Responsible for the Clinical Significance, Medical Summaries, and any other medical/clinical portions of Periodic Reports to the FDA
- Serve as medical expert for internal functions
- Oversee and coordinate any medical evaluations for RiskMAP/REMS obligations
- Direct Company Core Data Sheet development, review, and update
- Serve as Drug Safety Physician in support of Clinical Operations
- Serve as back-up Medical Reviewer for Promotion and Advertising Review Committee (PARC) as needed