and risk management keywords.
Company: Cencora (Affiliated with PharmaLex India Private Limited)
Locations: Hyderabad, Telangana, India | Mumbai, Maharashtra, India
Employment Type: Full-Time, Permanent
Category: Consulting / Pharmacovigilance & Drug Safety
Experience Required: Minimum 8 Years
Job ID: R2523541
Cencora is seeking an experienced Manager – Drug Safety Physician to lead pharmacovigilance (PV) and risk management activities across therapeutic areas. This role involves providing medical review and oversight of Individual Case Safety Reports (ICSRs), ensuring regulatory compliance, and mentoring PV teams.
The ideal candidate will have a medical degree, substantial PV experience, and strong expertise in drug safety, epidemiology, and risk assessment. This position offers the opportunity to work on complex global safety cases, interact with cross-functional teams, and contribute to improving patient outcomes.
Conduct initial assessment and medical review of ICSRs in the safety database, ensuring data accuracy and compliance with PV standards
Review adverse event details, seriousness criteria, MedDRA coding, suspect drug, concomitant medications, lab results, medical history, and labeling
Evaluate causality and provide Company Causality Comments
Respond to queries and comments from Case Owners in the safety database
Escalate complex case issues to Team Leads or Line Managers as required
Identify and document required follow-up information in the safety database
Maintain comprehensive documentation of medical review and case comments in accordance with internal workflows
Train and mentor PV associates on case processing, event capturing, and general pharmacovigilance conventions
Acquire and maintain current knowledge of product safety profiles across therapeutic areas
Support regulatory and internal compliance through high-quality PV documentation and reporting
Education: Medical Degree (MBBS or equivalent); Postgraduate degree in any discipline is advantageous but not mandatory
Experience: Minimum 8 years in Pharmacovigilance, Drug Safety, and Risk Management within the pharmaceutical or life sciences industry
Strong knowledge of ICSR processing, MedDRA coding, causality assessment, and PV regulations
Familiarity with safety databases and case management systems
Excellent analytical, organizational, and decision-making skills
Strong interpersonal and team management abilities
High sense of responsibility, dedication, and ability to work under pressure
Service-oriented with attention to detail and compliance standards
Effective communication skills in English – both written and spoken
Ability to mentor and guide junior PV team members
Cencora offers a dynamic environment to contribute to global pharmacovigilance and drug safety initiatives, with opportunities for professional growth and impact on patient safety. Benefits may vary by location and are aligned with local market practices.
Equal Employment Opportunity: Cencora is committed to providing equal opportunity in employment without discrimination on race, color, religion, sex, sexual orientation, gender identity, age, disability, veteran status, or any other legally protected class. Reasonable accommodations are available for candidates with disabilities during the recruitment process.
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