Job Summary
A clinical and scientific staffing company needs applicants for an opening for a Remote Pharmacovigilance Director in Norwood.
Must be able to:
- Provide scientific/clinical support for safety and benefit-risk evaluations and manage potential safety issues
- Evaluate all safety data for safety signals, including oversight of aggregate reporting for all products
- Lead the signal management process for assigned product(s) and evaluates safety data as part of ongoing pharmacovigilance activities
Applicants must meet the following qualifications:
- 7+ years’ experience in Pharmacovigilance, drug safety, risk management
- Minimum Bachelor's degree in life sciences
- Ability to serve as key analytic and safety support lead in close collaboration with the heads of medical, clinical and regulatory
- Demonstrated ability to assimilate clinical data and deliver succinct assessments and communicate effectively in verbal and written formats
- Ability to support safety related activities for global clinical trials
- Ability to lead aggregate report management including strategy, review and finalization of aggregate safety reports such as PADERs, PBRERs, and DSURs
