Sanofi Group Pharmacovigilance Scientist in Cambridge, Massachusetts
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. 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.
Knowledge 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.
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.
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.
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.