Sanofi Group Associate Director, PV Scientist in Cambridge (U.S.), Massachusetts

Associate Director, PV Scientist


Sanofi US

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.

Commitment is ourStrength. Ready to grow together?

Sanofi US endeavors tomake our career center accessible to any and all users. If you are experiencingdifficulty and need assistance applying online, please call 1-800-207-8049Option 7, then Option 3.

Sanofi US Services,Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Actionemployers committed to a culturally diverse workforce. All qualifiedapplicants will receive consideration for employment without regard to race;color; creed; religion; national origin; age; ancestry; nationality; marital,domestic partnership or civil union status; sex, gender, gender identity orexpression; affectional or sexual orientation; disability; veteran or militarystatus or liability for military status; domestic violence victim status;atypical cellular or blood trait; genetic information (including the refusal tosubmit to genetic testing) or any other characteristic protected by law.

PV Scientist

The Pharmacovigilance Scientist(PVS) is an experienced scientist assisting the SSRM Areas with:

  • Signaldetection

  • 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

-Literature review

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