Pharmacovigilance Scientist
Location: Bridgewater, NJ
About the Job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
The Patient Safety & Pharmacovigilance aspiration is to be a cutting-edge 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.
We 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?
PVS Main 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).
About You
Experience:
- 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 synthesis of scientific data.
- Signal & Risk Management: Expertise in the collection of drug safety information from a variety of sources throughout the product lifecycle to proactively detect, validate, and assess potential signals.
Soft skills:
- 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.
Technical skills:
- 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.
Education:
- 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.
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).
- Working knowledge of common data processing software (i.e., Excel, PowerPoint, Word) and database systems.
Languages:
- English proficiency in communication skills with scientific subject matter.
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.
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