Sanofi Group Associate Director, PV Scientist in Cambridge (U.S.), Massachusetts
Associate Director, PV Scientist
At Sanofi US, we arecommitted to the growth of our people, connected in purpose by career, life andhealth.
Headquartered in Bridgewater,NJ, Sanofi US is part of a leading global healthcare company dedicated todiscovering, developing and distributing therapeutic solutions focused onpatients’ needs.
Sanofi has corestrengths in diabetes solutions, human vaccines, innovative drugs, consumerhealthcare, emerging markets, animal health and Genzyme.
Sanofi US employsapproximately 17,000 people across the country all dedicated to protectinghealth, enhancing life and responding to the hopes and potential healthcareneeds of seven billion people around the world.
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The Pharmacovigilance Scientist(PVS) is an experienced scientist assisting the SSRM Areas with:
Safetyand benefit-risk evaluations for assigned products
Managementof potential safety issues for assigned products
The PVS will evaluate the respective databases for safetysignals and, in collaboration with Global Safety Officers (GSOs), formulateresponses to regulatory inquiries on product safety issues.
Main tasks include:
- Review of literature and review andsummary of large safety data sets
§presentation of results in draft reports
- Developmentand review of documents such as RMPs, DRMPs, ad-hoc responses and PSUR and IBcontributions.
Evaluation of safetydata for assigned products:
-Case series review or review of tabulated data
-Interpretation of reviewed data
Contributes to or develops Development Risk ManagementPlans and Risk Management Plans in the Compound Strategy Document or equivalentdocument, in collaboration with the GSO and the SSRM Center of Excellence forRisk Management
Signal detection and data mining in collaboration withthe GSO and the SSRM Center of Excellence for Signal Detection
Drafting of reports and writing and/or review of keydocuments in the context of safety and benefit risk for assigned products (RMP,Health Hazard Evaluation, IB, NDA submissions, ad hoc expert reports,supporting documents for the assignment offrequency categories to ADRs)
Overview of key safety information and draft summaryof documents supporting responses to Health Authorities and Affilitate queries,Ethics committees, revision of company core safety data sheets; drafting of(sections of) and/or assisting GSO with Clinical Overviews, Summary of ClinicalSafety, Investigator’s Brochures, etc
Initiating and reviewing searches of safety data inrespective databases
Providing input into periodic reports (PSUR, BR, AR,ASR, DSUR)
Acquire and maintain therapeutic area knowledge andongoing assessment of therapeutic areas, competitive products andtherapies
PharmD or PhD or equivalent professional experience with previous experience within the pharmaceutical industry and with previous advanced experience in medical / scientific writing and data analysis.
Knowledge of general medicine
Familiarity with industry principles of product safety, risk management, product development, pharmacology, biostatistics, clinical trial methodology and safety epidemiology
Ability to critically assess literature reports and internal study reports
Knowledge of common data processing software and word processing software.
Excellent verbal and written communication skills.
Interpersonal skills: Team player with internal and external networking skills. Ability to thrive in a global, matrix environment. Ability to manage high workload and critical issues.
Medical knowledge specific to the SSRM Area, e.g. Diabetes, Oncology, Devices, Personalized Genetic Health, Multiple Sclerosis. #LI-SA
Job: Pharmacovigilance & Epidemiology
Primary Location: United States-Massachusetts-Cambridge (U.S.)
Job Posting: Sep 7, 2016, 1:02:14 PM
Job Type: Regular
Employee Status: Regular