Pharmacovigilance Scientist

Sanofi • Swiftwater, PA

396d

About The Position

The Pharmacovigilance Scientist at Sanofi is a safety expert responsible for performing core pharmacovigilance activities on products, collaborating with the Global Safety Officer (GSO) to identify safety signals and analyze safety data for both marketed products and those in clinical development. This role is crucial in accelerating drug discovery and development, ultimately improving patient outcomes.

Requirements

• 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
• 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
• 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
• 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.

Nice To Haves

• 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

• High-quality healthcare
• Prevention and wellness programs
• At least 14 weeks' gender-neutral parental leave
• Opportunities for career growth and development

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 10,001+ employees