About this role
Role Overview
- Accountable for safety across the study
- Provide study team with medical advice for all medical issues during risk assessment
- Ensure development of and adherence to the Safety Surveillance Review Plan (SSRP)
- Monitor study safety issues and provide input to serious adverse events (SAEs) reports
- Participate in the Safety Review Team to evaluate medical benefits/risks
- Provide clinical input to protocol/study team for monitoring guidelines and statistics analysis plans
- Conduct medical review and interpretation of efficacy and safety data from clinical trials
- Author clinical sections of regulatory documents
Requirements
- Medical degree (M.D./D.O. or equivalent)
- 4+ years’ work experience
- Licensed by a health authority to prescribe medicines for at least two years
- Documented experience in the pharmaceutical industry related to clinical research programs and registration activities
- Ability to critically evaluate medical/scientific information
- Understanding of the design, development, and execution of clinical programs and studies
Benefits
- 401(k) plan with Pfizer Matching Contributions
- Additional Pfizer Retirement Savings Contribution
- Paid vacation, holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental and vision coverage