The Safety Surveillance Physician (SSP) will primarily be for Individual Case Medical Review in the Oncology Therapeutic area.
- SSPs are responsible for the medical assessment of case level and aggregate safety data for new safety concerns and trends and the communication of these issues to the Medical Safety Officer (MSO) and the Safety Management Team.
- Additionally, SSPs participate in matrix management activities (Safety Management Team core member) and providing pharmacovigilance expertise on individual case reports and signal detection methods.
- SSPs support SMT activities such as evaluating safety issues, preparation of aggregate safety reports such as PBRERs, ad-hoc regulatory reports, Risk Management Plans, and interpretation of surveillance and product quality data.
- Additionally, SSPs provide medical expertise in activities such as managing products or project teams, participating on cross-functional teams such as SOP committees, taskforces, work streams and representing GMSO positions, processes and guidances to external business partners.
- Medical degree from a recognized medical institution.
- Board Certified/Board Eligible/equivalent or 2 years post-graduate training or combination of 5 years of post-graduate training in a recognized medical specialty plus clinical medical experience is acceptable.
- An unrestricted medical license or equivalent or eligibility in one of the territories of GMS operations required.
- Familiarity with pharmaceutical industry principles of drug development and pharmacovigilance is preferred but not required.
Sneha
732-549- 5307
