The Pharmacovigilance Scientist (PVS) will serve as a core member of the safety team and is responsible for performing proactive pharmacovigilance activities on a product, or group of products in a therapeutic area or franchise, in partnership with the Global Safety Officer (GSO) to evaluate safety data and signals for both marketed products and products in clinical development. This includes performing signal detection and safety management committee activities, authoring safety evaluations, contributing and reviewing of aggregate safety reports, assisting with ad hoc regulatory responses, facilitating signal management process for assigned products (i.e., signal tracking, data analysis, leading review meetings, presenting, etc.) in collaboration with the GSO and Pharmacoepidemiology. Additionally, the PVS will support the GSO with 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/RMP and REMS. The PVS will provide coordination and oversight to outsourced activities (i.e., signal detection reports, clinical overviews).
+ Manage ongoing core signal detection activities for safety physician review (involves synthesis of data from multiple sources and critical thinking skills as well as authoring periodic signaling reports). Delivers the preparation and maintenance of safety sections of the Company Core Data Sheet
+ Coordinates and authors responses to Health Authority questions or responses to inquiries from internal or external stakeholders in collaboration with the Safety Team; includes proposing a strategy for the response & review of relevant data.
+ Is a Core member of the Safety Management Team who drives the agenda, produces the necessary data outputs, prepares slide presentations, facilitating discussions & documenting conclusions, and presents complete safety analysis.
+ Provides safety content for new drug applications and other regulatory filings including review of the safety and benefit risk sections, review and preparation of relevant safety sections to ensure consistency across documents and support response preparation
+ Drafts the Developmental Risk Management Plans (DRMPs) and safety sections of the EU Risk Management Plan (RMPs) for Safety Team for review and comment.
+ Applies product knowledge in providing medical safety contributions to periodic safety reports (ie. DSUR) for assigned development products
+ Generates applicable outputs for the Independent Data Monitoring Committee (IDMC) and the review of aggregate safety data.
+ Represents Global Pharmacovigilance on cross functional governance product team meetings 9. Manages the benefit-risk process and contributes to risk assessment and benefit risk assessment for marketed products
+ Coordinates and oversees outsourced activities (i.e., signal detection reports, safety evaluation reports)
+ Assists the Pharmacovigilance Science Manager in negotiating service agreements with strategic sourcing partners when applicable
+ Implements safety tools and applications adopted for use by Global Pharmacovigilance
+ Minimum Bachelors of Science or Health Care Professional (RN, BSN, Nurse Practitioner or Physician Assistant, RPh); or preferred advanced health care discipline degree (PharmD, PhD, Masters of Science, etc.) or equivalent qualification.
+ 2 years with relevant experience (including industry experience) with a working knowledge of drug safety and risk management, and understanding of drug development, basic knowledge of regulatory guidelines and medical coding (i.e. MedDRA).
+ Working knowledge of common data processing software (i.e., Excel, PowerPoint, Word) and database systems
Sanofi 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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity 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 diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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
Associated topics: bacteria, biomedical, biopharmaceutical, cytometry, diet, dietary, histologist, nephrology, pharmacy, physiologist
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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