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Pharmacovigilance Scientist New




Bridgewater, United States

United States





Not specified

Permanent | Full Time

Position Overview:The Pharmacovigilance Scientist (PVS) is a Safety Expert who is responsible for performing core pharmacovigilance activities on a product, or group of products in a therapeutic area or franchise, in partnership with the Global Safety Officer (GSO) to identify signals and evaluate safety data for both marketed products and products in clinical development. This includes performing proactive signal detection and safety management committee activities, authoring safety evaluations, defining scope and methodology, in agreement with the GSO, for aggregate safety reports, conducting preliminary safety analysis, preparing ad hoc Health Authority responses, driving the end-to-end signal management process for assigned products (i.e., signal tracking, data analysis, leading review meetings, presenting, etc.) in collaboration with the GSO and Pharmacoepidemiology. The PVS also partners with the Safety Team to manage other safety related activities associated with new drug applications / regulatory filings, benefit risk assessment and safety risk management and support activities related to risk minimization including dRMP/RMPs. The PVS manages the coordination and oversight to outsourced activities (i.e., signal detection reports, safety evaluation reports).Key Responsibilities:The nature and scope of PVS vendor oversight include the following activities specific to Global Business Unit(GBU):* Determines tasks to be outsourced on a unit.* Oversees tasks outsourced to service providers for respective GBU.* Provides clear direction to vendor for expected deliverables and timelines for completion.* Provides background information and necessary interval and cumulative data for safety analysis(es) including (but not limited to) most current company core labeling and PBRER, signal source, and safety database and literature outputs.* Resolves vendor questions and escalates issues to in-house PV Science Manager as appropriate.* Provides regular vendor feedback to in-house PV Science Manager for inclusion into the Vendor Operational Governance Meetings.* Reviews and approves vendor invoices related to outsourced PVS tasks to ensure accuracy of unit charges for respective GBU.Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally perse 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.#GD-SA#LI-SAAt Sanofi persity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness persity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the persity of our people, their backgrounds and experiences and provide equal opportunity for all.Apply For Role My Candidate Account

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