Pharmacovigilance Physician

Job description

Pharmacovigilance Physician Position Summary: The Pharmacovigilance Physician is a medical physician (MD , DO, or equivalent) who has the scientific, clinical and therapeutic area expertise responsibility for medical review of individual case safety reports (ICSR) to determine benefit- risk analysis and provide medical assessment statements, review and analyze aggregate data sets from internal or external sources for benefit-risk assessments, review and interpretation of clinical and post marketing data for the purpose of signal detection, evaluation, verification, and participation in safety meetings with clients. The physician will also assist in drafting, reviewing, and refining medical-content intensive portions of periodic safety reports (PADERs, PSURs, DSURs, PBRERs, IND Annual Reports), Investigators Brochure (IB) updates, Clinical Safety Summaries (ISS), US and international product labeling documents, and ad hoc safety information requests from regulatory authorities. This position is also responsible, as required, for drafting, reviewing, and refining risk management plans and risk evaluation and mitigation strategies for the client. The Pharmacovigilance Physician will a...