Job Title: Pharmacovigilance Science Expert
Location: Hyderabad, India
Job Type: Permanent
Posted on: April 8, 2025
Closing Date: May 7, 2025
Experience Required: 5-8 years
Qualifications: Master's in Pharmacy, Health Science, Physician Assistant, MBBS, BDS, or equivalent
Languages Required: Fluent in English (verbal and written)
Job Description:
The Pharmacovigilance (PV) Science Expert will play a critical role in the global safety surveillance of products throughout their lifecycle. The role involves managing signal detection, evaluating safety data, and collaborating with the Global Safety Lead/Managers (GSLs/GSMs). The expert will contribute to health hazard evaluations, safety evaluation reports, and support regulatory filings. The position requires a deep understanding of pharmacovigilance practices and the ability to work cross-functionally to support safety management and risk assessment.
Key Responsibilities:
Manage ongoing core signal detection activities and review data from multiple sources.
Author health hazard evaluations (HHEs) and safety evaluation reports (SERs).
Track and manage signals and support the use of the SMART tool.
Review and contribute to periodic signal detection reports.
Collaborate with the Safety Team in responding to Health Authority inquiries.
Contribute to the Safety Management Committee (SMC) and prepare presentations.
Support Global Safety Leads/Managers (GSL/GSM) in the preparation of new drug applications, Risk Management Plans (RMPs), and other regulatory filings.
Lead and contribute to risk assessment and benefit-risk evaluation for marketed products.
Work with cross-functional teams including Medical Safety, Regulatory Affairs, and PV Operations.
Provide OTC SWITCH SER support and mentor new PV safety scientists.
Assist with audit and inspection preparations and process-related queries at the user level.
Experience and Skills:
Drug Safety and Risk Management: 5-8 years of experience in drug safety, with a strong understanding of drug development, regulatory guidelines, and medical coding.
Pharmacovigilance Practices: Knowledge of US and EU pharmacovigilance regulatory requirements is appreciated.
Signal & Risk Management: Expertise in collecting, detecting, validating, and assessing safety signals throughout the product lifecycle.
Evaluation & Interpretation: Proficient in evaluating and synthesizing scientific data and regulatory guidelines.
Technical Skills: High attention to detail, problem-solving abilities, and proficiency in pharmacovigilance software and tools.
Soft Skills: Strong negotiation, communication, and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment and think strategically.
Required Qualifications:
Educational Background: Master’s degree in Pharmacy, Health Science, Physician Assistant, MBBS, BDS, or equivalent.
Experience: 5-8 years in pharmacovigilance, with experience in signal detection and safety management.
Language: Fluent in English (both written and verbal).
About Sanofi:
Sanofi is committed to progress and creating opportunities for extraordinary people to make a difference. The company fosters a diverse and inclusive environment and offers equal opportunities to all employees.
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