Senior Pharmacovigilance Scientist at Sanofi, Candidates from Healthcare Discipline- Apply Now
Are you a skilled and experienced Pharmacovigilance professional with a healthcare discipline degree and 3-6 years of industry experience? Sanofi, a leading global healthcare company, is seeking a dedicated Senior Pharmacovigilance Scientist to join our global Pharmacovigilance team in Hyderabad. If you possess a strong understanding of drug safety, risk management, and regulatory guidelines, and have excellent communication and collaboration skills, we encourage you to apply!
Job Posting: Senior Pharmacovigilance Scientist
- Role: Pharmacovigilance Science Expert
- Location: Hyderabad
Main Responsibilities: The Pharmacovigilance (PV) Science Expert is a global role, and it supports an international, dynamic, and culturally diverse team dedicated to safety surveillance throughout the product lifecycle of a broad range of products.
Your responsibilities will include:
- Managing ongoing core signal detection activities for Global Safety Leads/Managers (GSLs/GSMs) review (involve synthesis of data from multiple sources: PV database, literature, PV textbooks, and external DBs)
- Coordinating and authoring draft health hazard evaluations (HHEs) and/or safety evaluation reports (SERs)
- Reviewing periodic signal detection reports (NINR, UDR, SD reports for PBRERs)
- Contributing to responses to Health Authority questions or inquiries from internal or external stakeholders in collaboration with the Safety Team
Accountabilities:
- Supporting GSL/GSM to provide safety content for new drug applications and other regulatory filings
- Collaborating with various stakeholders, including PV Quality, Medical Safety, Regulatory Affairs, and PV vendors
- Supporting in audit and inspection preparation
About You:
Experience:
Working knowledge of drug safety and risk management, including 3-6 years industry experience, and understanding of drug development, basic knowledge of regulatory guidelines, and medical coding.
Soft Skills:
Stakeholder management, strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions.
Technical Skills:
Evaluation, interpretation, and synthetization of scientific data, knowledge of pharmacovigilance practices, signal & risk management expertise, proficiency in international regulations, guidelines good practices.
Education:
Preferred health care discipline degree in modern science.
Languages:
Fluent in English (verbal and written)
Keywords: Senior Pharmacovigilance Scientist, Sanofi, Hyderabad, Drug Safety, Risk Management, Regulatory Guidelines, Pharmacovigilance Practices, Signal Detection, Risk Assessment
