Pharmacovigilance Scientist

Sanofi US; Gentilly; Sur place; EUR 45 000 - 65 000; Plein temps

Résumé du poste

Une entreprise biopharmaceutique recherche un(e) Pharmacovigilance Scientist pour gérer la sécurité des produits durant leur cycle de vie. En collaborant avec des équipes internationales, vous serez responsable des activités de pharmacovigilance, de l'évaluation des risques et de la gestion des signaux de sécurité. Les candidats doivent avoir une bonne connaissance des réglementations et des pratiques en matière de pharmacovigilance, ainsi qu'un baccalauréat en sciences ou un diplôme de santé. Rejoignez une équipe dynamique et engagée.

Prestations

Package de récompense bien conçu

Avantages en matière de santé et de bien-être

Congés parentaux de 14 semaines

Qualifications

• Minimum une expérience en sécurité des médicaments et en réglementation.
• Capacité à interpréter et synthétiser des données scientifiques.
• Expertise en gestion des signaux de sécurité souhaitée.

Responsabilités

• Gérer la détection proactive des signaux de sécurité.
• Rédiger des évaluations de sécurité et des réponses aux questions.
• Coordonner les activités sous-traitées liées à la sécurité.

Connaissances

Connaissance de la sécurité des médicaments

Analyse des données scientifiques

Gestion des signaux de sécurité

Travail d'équipe

Formation

Baccalauréat en sciences ou diplôme de santé

Outils

Logiciels de traitement de données

Description du poste

Pharmacovigilance Scientist

• Location: Gentilly, FR

Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail.

This job offer is accessible to all, regardless of gender.

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. Join our Patient Safety & Pharmacovigilance team as a Pharmacovigilance Scientist (PVS) and you’ll support 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.

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/regulatoryfilings, 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)

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
• Evaluation, interpretation, and synthetization of scientific data
• Knowledge of pharmacovigilance practices including US and EU pharmacovigilance regulatory requirements appreciated
• 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 appreciated

Soft and technical 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
• 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.

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

Equal Opportunity

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or other characteristics protected by law.

Pursue Progress and Discover Extraordinary – together.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!