The Global Pharmacovigilance aspiration is to be a cutting-age safety group, to enable us to optimize the benefit-risk of our therapies, so we can best serve our patients and consumers.
The pharmacovigilance scientist group is an international, dynamic, and culturally diverse team dedicated to safety surveillance throughout the product lifecycle of a broad range of products.
The Pharmacovigilance Scientist (PVS) is a Safety Expert who is responsible for performing core pharmacovigilance activities on a product, in partnership with the Global Safety Officer (GSO), to identify safety signals, evaluate, and analyze safety data for both marketed products and products in clinical development.
Manages proactive signal detection and safety management committee activities
Coordinates and authors safety evaluations and responses to safety inquiries from internal or external stakeholders (i.e. Health Authorities) in collaboration with the safety team
Drives end-to-end signal management process for assigned products in collaboration with the GSO and Pharmacoepidemiology
Serves as a core member (coordinator) of the Safety Management Team, drives the agenda, produces the necessary data/outputs, prepares slide presentations, facilitates discussions & documents conclusions, and presents complete safety analysis
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 development Risk Management Plans
Coordinates and oversees outsourced activities (i.e., signal detection reports, safety evaluation reports)
Working knowledge of drug safety and risk management including industry experience, and understanding of drug development, basic knowledge of regulatory guidelines and medical coding
Strong knowledge of pharmacovigilance practices including US and EU pharmacovigilance regulatory requirements
Evaluation, interpretation, and synthetization of scientific data
Signal & Risk Management: Expertise in the collection of drug safety information from a variety of sources throughout the product life cycle to proactively detect, validate, and assess potential signals.
Team player that performs effectively in a cross-functional collaborative environment
Self–motivated, able to relentlessly prioritize, plan effectively and independently
Strategic, business oriented, and problem solving mindset while keeping patients and customers at the forefront
Ability to present and critically discuss safety data in both internal and external discussions
Working knowledge of common data processing software and database systems
Project management skills with demonstrated attention to detail, keeping in mind the broader picture
Bachelor of Science or Health Care Professional or preferred advanced health care discipline degree including Registered Nurse, Bachelor of Science in Nursing, Nurse Practitioner, Doctor of Pharmacy, PhD, Master of Health Science, Physician Assistant, Registered Pharmacist, Doctor of Medicine / Doctors of osteopathy, etc.
English proficiency in communication skills with scientific subject matter
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.