Case Medical Evaluator

Sanofi-Synthelabo and Aventis Pharmaceuticals, part of the sanofi-aventis Group are facing the future and leading the way as the 3rd largest pharmaceutical company in the world and number 1 in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven therapeutic areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, and vaccines.Embrace this opportunity to join a diverse and talented group of individuals championed to take on innovation and change in our rapidly expanding organization.Job Summary:
Medical evaluation of all adverse events for assigned products.
Participate in signal detection for assigned products.
Prompt identification and immediate communication of potential alert reports and safety signals to the Global Safety Officer.Duties & Responsibilities:
1. Individual Case Reviews: For assigned products, reviews all individual adverse event reports for clinical and regulatory assessment. Directs follow-up for serious cases. Approval of all individual case reports to regulatory authorities (all serious/listed/(associated) cases). Identify all SUSAR cases for prompt review by GSO.
2. Identification of potential safety signals and informing Global Safety Officer of all potentially-important cases and issues.
3. Coordination of safety activities within CMPU for assigned products : serves as expert for documentation, quality of cases, PTC evaluation, DEUP cases.
REQUIREMENTS
Knowledge & Skills:
Knowledge of medical diagnosis and treatment
Procedures and guidelines SOPs, (Working practices)
Pharmacovigilance Database
English
Excellent written and verbal communication skillsEducation/ Experience:
PharmD or MD required. Minimum of 3 years patient-care experience