About the JobWe are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?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).Major Duties and Responsibilities
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. Support the preparation and maintenance of safety sections of the Company Core Data Sheet
Coordinates and authors responses to regulatory agencies or responses to inquiries from internal or external stakeholders in collaboration with safety physician; includes proposing a strategy for the response & review of relevant data. In partnership with the safety physician, provide strategic input and review of applicable sections of the PBRER and DSUR to ensure that aggregate data analyses is consistent with overall product safety profile
Core member of the Safety Management Team, including setting agenda, producing necessary data outputs, preparing slide presentations, facilitating discussions & documenting conclusions.
Provide 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
Collaborates with the safety physician in preparation and authoring developmental Risk Management Plans (DRMPs), safety sections of the EU Risk Management Plan (RMPs) and Risk Evaluation and Mitigation Strategy Plans (REMS).
Supports safety related activities for clinical trials, including review of protocols, statistical analysis plans, safety content of Investigator Brochures and clinical study reports as well as perform aggregate safety data review.
Represents Pharmacovigilance on study teams, cross functional product teams, etc.
About youKnowledge and Skills
Good knowledge of pharmacovigilance practices
Good knowledge of US and EU pharmacovigilance regulatory requirements
Excellent written and verbal communication skills
Ability to present and critically discuss safety data in both internal and external discussions
Ability to evaluate, interpret and synthesize scientific data (analytical thinking)
Team player with ability to function in a cross-functional environment
Self–motivated, able to prioritize and plan effectively, and independently, with minimal supervision
Fluent in English (verbal and written)
Good moderator skills
Ability to navigate in databases and pull information correctly
Good organizational skills and attention to detail
Formal Education and Experience Required:Education
Must be enrolled in Sanofi Fellowship Program.
Minimum Bachelors of Science or Health Care Professional (RN, BSN, Nurse Practitioner or Physician Assistant, RPh); or preferred advanced health care discipline degree (MDPharmD, PhD, Masters of Science, etc.) or equivalent qualification.
Experience
Preferred 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).
Basic knowledge of common data processing software (i.e., Excel, PowerPoint, Word) and database systems
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
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.#GD-SA#LI-SA#LI-Onsite
