Pharmacovigilance Scientist

Sanofi • Morristown, NJ

8d • Onsite

About The Position

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. The Patient Safety & 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 (PVS) group is an international, dynamic, and culturally diverse team dedicated to safety surveillance throughout the product lifecycle of a broad range of products. The 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. About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Requirements

• 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.
• 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 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
• 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 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 discussion
• Project management skills with demonstrated attention to detail, keeping in mind the broader picture
• Working knowledge of common data processing software (i.e., Excel, PowerPoint, Word) and database systems
• English proficiency in communication skills with scientific subject matter

Responsibilities

• 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 of Risk Management Plans
• Coordinates and oversees outsourced activities (i.e., signal detection reports, safety evaluation reports)

Benefits

• 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 a 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level