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Pharmacovigilance Scientist

Company name
Sanofi-Aventis U.S. LLC

Bridgewater, NJ

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SUMMARY: The Pharmacovigilance Scientist (PVS) will serve as a core member of the safety team and is responsible for\u00a0performing proactive pharmacovigilance activities on a product, or group of products in a therapeutic area or\u00a0franchise, in partnership with the Global Safety Officer (GSO) to evaluate safety data and signals for both marketed\u00a0products and products in clinical development. This includes performing signal detection and safety management\u00a0committee activities, authoring safety evaluations, contributing and reviewing of aggregate safety reports, assisting\u00a0with ad hoc regulatory responses, facilitating signal management process for assigned products (i.e., signal\u00a0tracking, data analysis, leading review meetings, presenting, etc.) in collaboration with the GSO and\u00a0Pharmacoepidemiology. Additionally, the PVS will support the GSO with other safety related activities associated\u00a0with new drug applications \/ regulatory filings, benefit risk assessment and safety risk management and support\u00a0activities related to risk minimization including dRMP\/RMP and REMS. The PVS will provide coordination and\u00a0oversight to outsourced activities (i.e., signal detection reports, clinical overviews).\u00a0 MAJOR DUTIES & RESPONSIBILITIES: 1.\u00a0Manage ongoing core signal detection activities for safety physician review; involves synthesis of data from\u00a0multiple sources and critical thinking skills as well as authoring periodic signaling reports. Support the\u00a0preparation and maintenance of safety sections of the Company Core Data Sheet\u00a0 2.\u00a0Coordinates and authors responses to regulatory agencies or responses to inquiries from internal or external\u00a0stakeholders in collaboration with safety physician; includes proposing a strategy for the response & review\u00a0of relevant data. In partnership with the safety physician, provide strategic input and review of applicable\u00a0sections of the PBRER and DSUR to ensure that aggregate data analyses is consistent with overall product\u00a0safety profile\u00a0 3.\u00a0Core member of the Safety Management Team, including setting agenda, producing necessary data\u00a0outputs, preparing slide presentations, facilitating discussions & documenting conclusions.\u00a0 4.\u00a0Provide safety content for new drug applications and other regulatory filings including review of the safety\u00a0and benefit risk sections, review and preparation of relevant safety sections to ensure consistency across\u00a0documents and support response preparation\u00a0 5.\u00a0Collaborates with the safety physician in preparation and authoring developmental Risk Management Plans\u00a0(DRMPs), safety sections of the EU Risk Management Plan (RMPs) and Risk Evaluation and Mitigation\u00a0Strategy Plans (REMS).\u00a0 6.\u00a0Supports safety related activities for clinical trials, including review of protocols, statistical analysis plans,\u00a0safety content of Investigator Brochures and clinical study reports as well as perform aggregate safety data\u00a0review.\u00a0 7.\u00a0Represents Pharmacovigilance on study teams, cross functional product teams, etc.\u00a0 BASIC QUALIFICATIONS: Minimum Bachelors of Science or Health Care Professional (RN, BSN, Nurse Practitioner or Physician Assistant,\u00a0RPh); \u2022 Good knowledge of pharmacovigilance practices\u00a0 \u2022 Good knowledge of US and EU pharmacovigilance regulatory requirements\u00a0 \u2022\u2022 Ability to present and critically discuss safety data in both internal and external discussions\u00a0 \u2022 Ability to evaluate, interpret and synthesize scientific data (analytical thinking)\u00a0 \u2022 Fluent in English (verbal and written)\u00a0 \u2022 Good moderator skills\u00a0 \u2022 Ability to navigate in databases and pull information correctly\u00a0 PREFERRED QUALIFICATIONS:\u00a0 Advanced health care degree in the following disciplines is preferred: (MD, PharmD, PhD, Masters of Science) \u2022 Preferred 2 years with relevant experience (including industry experience) with a working knowledge of drug\u00a0safety and risk management, and understanding of drug development, basic knowledge of regulatory guidelines\u00a0and medical coding (i.e. MedDRA).\u00a0 \u2022 Basic knowledge of common data processing software (i.e., Excel, PowerPoint, Word) and database systems\u00a0 The Successful candidate will possess the following Competencies:\u00a0 \u2022 Excellent written and verbal communication skills\u00a0 \u2022 Team player with ability to function in a cross-functional environment\u00a0 \u2022 Self\u2013motivated, able to prioritize and plan effectively, and independently, with minimal supervision\u00a0 \u2022 Good moderator skills\u00a0 \u2022 Ability to navigate in databases and pull information correctly\u00a0 Sanofi US Services, Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants 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 or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Sanofi, Empowering Life

Company info

Sanofi-Aventis U.S. LLC
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Company Profile
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patient's needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme.

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