December 13, 2023
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ā¢ Provide medical expertise and strategic direction ā¢ Oversee the medical safety team ā¢ Shape the strategy and implement pharmacovigilance and risk management activities ā¢ Collaborate cross-functionally with various teams ā¢ Perform medical review and analysis for safety reports ā¢ Lead interactions with regulatory authorities ā¢ Negotiate safety data exchange agreements with license partners and distributors ā¢ Lead Safety Review Management Team ā¢ Develop talent and provide leadership to the team
ā¢ Medical degree (MD/DO), PharmD, or equivalent ā¢ At least 2 years of experience in clinical/medical practice ā¢ 13+ years of related experience with 8+ years leading Safety Teams ā¢ Experience in authoring safety signal assessment reports, DSUR, PBRER, RMP, and RSI ā¢ Experience with signal detection process and managing safety information ā¢ Knowledge of Global regulations and ICH guidance ā¢ Knowledge of drug development process and pharmacovigilance databases
ā¢ Compensation, bonus and equity ā¢ Health, dental, vision, life and disability insurance benefits ā¢ Non-accrual paid time off ā¢ Company shut down for holidays ā¢ Commuter benefits ā¢ Child care reimbursement ā¢ Education reimbursement ā¢ 401K match ā¢ Lunch for all onsite employees
Apply NowSeptember 6, 2023
501 - 1000
šŗšø United States ā Remote
šµ $200k - $250k / year
š° $130M Private Equity Round on 2021-09
ā° Full Time
š Senior
š² Risk
š½ H1B Visa Sponsor