Manager – Drug Safety Physician
Location: Noida, India
Category: Pharmacovigilance / Consulting
Employment Type: Full-time
Experience Required: Minimum 8 years in Pharmacovigilance & Drug Safety
About Cencora:
Cencora is a global leader in healthcare solutions, committed to creating healthier futures for people and animals. With a focus on innovation and excellence, Cencora empowers its team to make meaningful contributions to patient safety and therapeutic advancement. Join a dynamic organization that values scientific rigor, collaboration, and integrity.
Role Overview:
Cencora is seeking a Manager – Drug Safety Physician to lead medical review and clinical assessment of Individual Case Safety Reports (ICSRs) and related pharmacovigilance activities. The ideal candidate will possess deep expertise in regulatory frameworks, clinical evaluation, and signal detection across multiple therapeutic areas. This role requires leadership, scientific acumen, and experience in a corporate pharmacovigilance environment.
Key Responsibilities:
Conduct medical review and clinical assessment of ICSRs within the safety database.
Verify accurate selection of adverse events, seriousness criteria, MedDRA coding, suspect drugs, concomitant medications, laboratory data, medical history, and labeling.
Review narratives and provide company clinical comments.
Respond to case owner queries in the patient safety database and provide guidance as needed.
Screen scientific literature for safety-relevant publications using internal and external resources.
Maintain strong knowledge of Good Pharmacovigilance Practices (GPVP), Good Clinical Practices (GCP), ICH guidelines, and EMA requirements.
Mentor and train PV associates on case evaluation, event capturing, and general pharmacovigilance practices.
Stay updated on product safety profiles across therapeutic areas.
Escalate complex or critical case issues to the Team Lead or Line Manager.
Participate in preparation of periodic safety reports (PSURs, PBRERs) and Risk Management Plans (RMPs).
Collaborate with the Global Pharmacovigilance team on signal detection and related processes.
Actively participate in internal project meetings, audits, and inspections.
Perform additional drug safety activities as assigned.
Educational Qualifications:
Degree in Medicine (MBBS required).
Postgraduate degree in any relevant discipline is advantageous but not mandatory.
Experience & Skills:
Minimum 8 years of relevant experience in pharmacovigilance and drug safety.
Hands-on experience in medical review of ICSRs, regulatory compliance, and signal detection.
Strong interpersonal and organizational skills with a collaborative mindset.
Ability to work under pressure with high responsibility and dedication.
Exposure to corporate pharmaceutical or life sciences environments is preferred.
Excellent written and verbal communication skills in English.
Knowledge of safety databases, regulatory guidelines, SOPs, and literature surveillance.
Core Competencies:
Clinical judgment and analytical skills for drug safety evaluation.
Leadership and mentoring capabilities for guiding junior PV team members.
Proficiency in global regulatory frameworks and GxP compliance.
Strong service orientation and proactive problem-solving approach.
Why Cencora:
Cencora provides competitive benefits aligned with local market practices and supports career growth in a collaborative, inclusive, and innovative environment.
Equal Opportunity Employer:
Cencora is committed to providing equal employment opportunities for all qualified individuals regardless of race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or other legally protected characteristics. Reasonable accommodations are available for qualified candidates with disabilities during the recruitment process.
Application Instructions:
Interested candidates are invited to submit their CV and cover letter via the Cencora careers portal, highlighting relevant experience in pharmacovigilance, drug safety, and clinical review.
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