• 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
• 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

PursueProgress.DiscoverExtraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

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

Watch ourALL IN videoand check out our Diversity Equity and Inclusion actions atsanofi.com!

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