Manager – Drug Safety Physician, Pharmacovigilance, Epidemiology & Risk Management
Location: Noida, India | Job ID: R2516638 | Category: Consulting | Employment Type: Full-Time
About Cencora
Cencora is a global leader in healthcare and life sciences, committed to creating healthier futures for people and animals worldwide. Our teams drive innovation in pharmacovigilance, epidemiology, and risk management to ensure patient safety and regulatory compliance across therapeutic areas. Join a dynamic organization where your expertise directly impacts global drug safety.
Position Overview
Cencora is seeking a Manager – Drug Safety Physician to lead and oversee pharmacovigilance activities, including Individual Case Safety Reports (ICSRs), periodic safety reports, and risk management plans. The role requires strong clinical judgment, regulatory knowledge, and leadership in supporting global pharmacovigilance operations.
Key Responsibilities
Conduct medical review and assessment of ICSRs in safety databases.
Review and validate adverse events, including seriousness criteria, MedDRA coding, causality, lab data, concomitant medications, and clinical narratives.
Respond to case owner queries and perform literature screening using internal and external sources.
Maintain up-to-date knowledge of Good Pharmacovigilance Practices (GVP), Good Clinical Practice (GCP), and ICH/EMA guidelines.
Train, mentor, and provide guidance to PV associates on event capturing and pharmacovigilance conventions.
Escalate complex case issues to Team Lead or Line Manager.
Conduct medical triage and classify safety-relevant publications for literature surveillance.
Prepare and review periodic safety reports (PSURs, PBRERs) and Risk Management Plans (RMPs).
Collaborate with global pharmacovigilance teams on signal detection and risk management processes.
Actively participate in internal project meetings and support audits or inspections.
Perform additional drug safety and pharmacovigilance activities as assigned.
Qualifications & Experience
Education: Degree in Medicine; Postgraduate degree is an advantage but not mandatory.
Experience: Minimum 8 years in Pharmacovigilance and Drug Safety within pharmaceutical, biotechnology, or CRO environments.
Strong interpersonal, organizational, and team leadership skills.
Excellent communication skills in English (spoken and written).
Ability to work under pressure with high responsibility and service orientation.
Why Join Cencora
Lead global pharmacovigilance projects with direct impact on patient safety.
Work in a collaborative and innovative environment with career growth opportunities.
Gain exposure to regulatory compliance, signal detection, and safety database management across multiple therapeutic areas.
Participate in global audits, inspections, and quality initiatives.
Equal Employment Opportunity
Cencora provides equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, age, disability, veteran status, or other legally protected classes. Reasonable accommodations are provided during the recruitment process.
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