Associate Director, Safety Science
- San Mateo, CA
- Permanent
- Full-time
- Perform signal detection activities, prepare aggregate safety reports, review ICSRs, and work with cross-functional team to evaluate safety signals
- Complete medical review of pre and post-marketing individual case safety reports (ICSRs) and/or aggregate safety data of products to ensure accuracy of ICSR MedDRA coding, assessments of seriousness, expectedness, causality, and regulatory reporting
- Collaborate with Clinical Science, Medical Affairs, PV colleagues and applicable functional specialists to identify, evaluate and manage safety signals
- Participate in the development of safety surveillance and risk management plans for drug development programs
- Assist with preparation and review safety sections of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, NDA/BLA/CTD submissions and other safety documents
- BSN, RN, PharmD, MD, DO or equivalent healthcare degree required
- Demonstrated biopharma experience with ICSR reviews in Argus safety database, quarterly signal evaluation forms, signal issue work-ups, aggregate reports and risk management plans.
- Experience working in a fast paced environment and collaborating with cross-functional teams
As an employee, you have access to a comprehensive benefits package including:
- Medical insurance PPO, HMO & HSA
- Dental & Vision insurance
- 401k plan
- Employee Assistance Program
- Long-term disability
- Weekly payroll
- Expense reimbursement
- Online timecard approval
- $250,000 to $270,400 (Dependent on Experience)