Manager – Drug Safety Physician
Function: Pharmacovigilance, Epidemiology & Risk Management
Job ID: R257963
Location: Noida, Uttar Pradesh, India
Employment Type: Full-Time
Category: Consulting
Posted Date: December 24, 2025
Company: Cencora (Affiliated Company: PharmaLex India Private Limited)
About Cencora
Cencora is a global healthcare services organization dedicated to creating healthier futures for people and animals worldwide. With innovation, integrity, and collaboration at its core, Cencora supports pharmaceutical, biotechnology, and life sciences organizations across the full product lifecycle. Every team member plays a critical role in advancing patient safety and public health.
Job Overview
The Manager – Drug Safety Physician will play a key role in Pharmacovigilance and Risk Management activities, providing expert medical oversight for individual case safety reports (ICSRs), literature surveillance, periodic safety reporting, and signal management. This position requires strong medical judgment, in-depth knowledge of global PV regulations, and close collaboration with global pharmacovigilance teams.
Key Responsibilities
Perform medical review and clinical assessment of Individual Case Safety Reports (ICSRs) in the safety database.
Review and verify adverse event selection from source documents, seriousness criteria, MedDRA coding, suspect and concomitant medications, laboratory data, medical history, labeling, causality assessment, and case narratives.
Provide clear and compliant Company Clinical Comments within safety cases.
Review and respond to case-related queries from case processors and safety associates within the patient safety database.
Conduct scientific literature screening and assessment using internal systems and external literature search tools.
Perform medical triage and classification of safety-relevant publications as part of literature surveillance activities.
Maintain strong working knowledge of GVP, GCP, ICH, EMA, and other global pharmacovigilance guidelines and ensure their appropriate implementation.
Train and mentor pharmacovigilance associates on adverse event identification, case processing conventions, and medical review standards.
Maintain up-to-date knowledge of product safety profiles across multiple therapeutic areas.
Escalate complex or high-risk safety issues related to client products to the Team Lead or Line Manager.
Participate in signal detection activities in collaboration with global pharmacovigilance teams.
Review and prepare periodic safety reports including PSURs, PBRERs, and Risk Management Plans (RMPs).
Actively participate in internal project meetings, audits, and regulatory inspections.
Maintain compliance with internal SOPs, databases, and regulatory requirements.
Perform additional drug safety and risk management activities as assigned.
Required Qualifications
Medical degree (MBBS or equivalent).
Postgraduate qualification in any medical discipline is an advantage but not mandatory.
Required Experience
Minimum 3 years of relevant experience in Pharmacovigilance, Drug Safety, Medical Review, or Risk Management.
Prior experience in pharmaceutical, biotechnology, CRO, or life sciences consulting environments is preferred.
Key Skills and Competencies
Strong knowledge of global pharmacovigilance regulations and guidelines (ICH, EMA, GVP).
Expertise in ICSR medical review, causality assessment, and safety data interpretation.
High attention to detail with strong analytical and organizational skills.
Ability to work effectively under pressure and manage multiple priorities.
Strong interpersonal and team collaboration skills.
Service-oriented mindset with experience working in corporate or client-facing environments.
Excellent written and verbal communication skills in English.
Proficiency in safety databases and standard office software tools.
Employment and Benefits
Benefit offerings may vary by country and are aligned with local market practices. Eligibility and effective dates may differ based on employment terms and local regulations.
Equal Employment Opportunity
Cencora is an equal opportunity employer and is committed to maintaining a diverse and inclusive workplace. Employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, veteran status, or any other legally protected characteristic.
Cencora also provides reasonable accommodations for individuals with disabilities during the employment process, in compliance with applicable laws.
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