Job Title:
Senior Pharmacovigilance Scientist
Location:
Hyderabad, India
Company:
Sanofi
Role Overview:
The Senior Pharmacovigilance Scientist (PV Science Expert) plays a global role within a diverse and international safety surveillance team. This position supports the full lifecycle of various products by identifying, evaluating, and analyzing safety data for both marketed products and those in clinical development.
Key Responsibilities:
Manage ongoing core signal detection activities for GSLs/GSMs, synthesizing data from multiple sources (PV database, literature, external databases, etc.)
Coordinate and author draft Health Hazard Evaluations (HHEs) and Safety Evaluation Reports (SERs)
Manage data entry and tracking of signals, ME, and INR in SMART tool; support SMART-related activities
Review periodic signal detection reports (NINR, UDR, SD for PBRERs)
Contribute to responses for Health Authority queries and stakeholder inquiries; support strategy and data review
Serve as a core member of the Safety Management Committee (SMC); prepare data outputs and presentations
Support safety content development for regulatory filings and new drug applications
Assist in drafting EU Risk Management Plans (RMPs)
Contribute to risk and benefit-risk assessments for marketed products
Collaborate with internal and external stakeholders across functions (Medical Safety, PV Quality, Regulatory, etc.)
Provide support for OTC SWITCH SER
Participate in audit and inspection preparation
Experience Required:
3–6 years of industry experience in drug safety and risk management
Basic understanding of drug development and regulatory guidelines
Experience in medical coding and interpreting scientific data
Soft Skills:
Strong stakeholder management, negotiation, and communication skills
Effective in a cross-functional, multicultural, and global environment
Excellent organization and project management abilities
Strategic thinking and leadership capability
Technical Skills:
Proficient in evaluating and synthesizing scientific data
Knowledge of US/EU pharmacovigilance regulatory requirements
Expertise in signal detection and risk management
Familiarity with international regulations and good practices in PV
High attention to detail; strong writing and analytical skills
Ability to work independently and as part of a team
Excellent collaboration and influencing skills
Education:
Preferred degrees:
Master’s in Pharmacy (M.Pharm)
Master of Health Science
Physician Assistant
MBBS
BDS
Languages:
Fluent in English (written and verbal)
Why Join Sanofi?
At Sanofi, progress is driven by people who are open to new ideas, embrace change, and are committed to discovering the extraordinary. We champion diversity, inclusion, and equal opportunity for all.
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