The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall Pharmacovigilance process; this includes aggregate signal detection activities for selected products. This includes the development of signal detection strategy. In addition, this position will also support oversight of vendors.
The Safety Surveillance Physician (SSP) has primary responsibility for determining the medical and scientific relevance of adverse event reports within the context of the product’s safety profile as well as other products within the same therapeutic area. These responsibilities include spontaneous reports, clinical and non-clinical studies, literature reports and other sources of safety data.
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 (SMT).
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.
EDUCATION & EXPERIENCE REQUIREMENTS:
Describe the minimum knowledge, skill and ability requirements for the position. Include any degrees or certifications which are required and/or desirable.
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.