April 16
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• Chair cross-functional SRMT to review safety data • Lead SRMT throughout product lifecycle • Provide input to safety related sections of clinical study documents • Perform medical review of Individual Case Safety Reports and Aggregate Safety Reports • Help negotiate safety data exchange/pharmacovigilance agreements • Assist in the maintenance of safety related cross-functional SOPs
• Medical degree (MD/DO), PharmD, or equivalent required • 8+ years of pharmaceutical industry experience in drug safety & pharmacovigilance • Experience in authoring safety signal assessment report, DSUR, PBRER, and RSI • Experience with global regulations and ICH guidance governing pharmacovigilance • Knowledge of drug development process, pharmacovigilance databases, and MedDRA coding • Familiarity with safety databases
• compensation, bonus and equity • health, dental, vision, life and disability insurance benefits • non-accrual paid time off • company shut down for holidays • commuter benefits • child care reimbursement • education reimbursement • 401K match • lunch for onsite employees
Apply NowApril 10
April 10
11 - 50
🇺🇸 United States – Remote
🔥 Funding within the last year
đź’° Private Equity Round on 2023-11
⏰ Full Time
đź”´ Lead
🎲 Risk
March 22
March 22
1001 - 5000
🇺🇸 United States – Remote
đź’° Venture Round on 2021-05
⏰ Full Time
đź”´ Lead
🎲 Risk
đź—˝ H1B Visa Sponsor