Role Title: Pharmacovigilance Science Expert
Location: Hyderabad
Company: Sanofi
Main Responsibilities
The Pharmacovigilance (PV) Science Expert is a global safety expert role supporting a culturally diverse, international team focused on safety surveillance across the product lifecycle of a broad range of products.
Key Accountabilities
Manage core signal detection activities and synthesize data from PV databases, literature, textbooks, and external databases.
Coordinate and draft Health Hazard Evaluations (HHEs) and Safety Evaluation Reports (SERs).
Manage entry and tracking of signals, Medical Events (ME), and Important New Risks (INR) in the SMART tool.
Review signal detection reports (e.g., NINR, UDR, SD reports for PBRERs).
Support responses to Health Authority inquiries with strategic input and data review.
Core member of Safety Management Committee (SMC) including slide preparation and data output.
Assist in preparing safety content for regulatory filings and New Drug Applications.
Draft and review safety sections of EU Risk Management Plans (RMPs).
Support risk and benefit-risk assessments of marketed products.
Coordinate meetings, agendas, and track action items for ongoing safety review.
Collaborate across functions including Medical Safety, PV Quality, Regulatory Affairs, Labeling, and vendors.
Provide support for OTC switch SERs.
Mentor new Pharmacovigilance Safety Scientists (PVSs).
Prepare for audits and inspections.
Address process-related user-level queries.
Lead projects as needed, serving as the primary contact and resolving project-related issues.
Required Experience
5–8 years of industry experience in pharmacovigilance and risk management.
Understanding of drug development and regulatory requirements.
Familiarity with medical coding and safety data evaluation.
Soft Skills
Strong communication and stakeholder management skills.
Effective in global, cross-functional, and multicultural environments.
Strong project management, organizational, and leadership skills.
Strategic thinking and team leadership abilities.
Technical Skills
Ability to synthesize scientific data for evaluation and interpretation.
Understanding of US/EU pharmacovigilance regulatory requirements.
Experience in signal and risk management throughout the product life cycle.
Knowledge of industry standards, guidelines, and Good Practices in PV.
High attention to detail, problem-solving, and writing skills.
Ability to work independently and collaboratively across teams.
Strong networking and influencing capabilities.
Commitment to ethics, regulations, and company protocols.
Education
Preferred: Degree in healthcare or modern science discipline such as:
M.Pharm / Master of Health Science / Physician Assistant / MBBS / BDS
Languages
Fluent in English (verbal and written)
Equal Opportunity Statement
Sanofi is committed to providing equal opportunities to all individuals regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Tagline
Pursue progress. Discover extraordinary.
Be a part of a global movement driven by innovation, diversity, and the desire to make miracles happen.
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