Job Summary
Cencora is seeking a Senior Manager (Level 1), Drug Safety Physician to lead pharmacovigilance, epidemiology, and risk management operations in Noida. This role involves managing ICSR projects, ensuring compliance with GPVP, ICH, EMA, and FDA guidelines, and mentoring PV associates. The ideal candidate will bring extensive experience in drug safety, adverse event review, and clinical risk management.
Key Responsibilities
Lead a team of Drug Safety Physicians on ICSR projects.
Conduct medical review and initial assessment of ICSR entries in the safety database.
Verify adverse event selection, MedDRA coding, causality assessment, and narrative review.
Train and mentor PV associates on event capturing and pharmacovigilance conventions.
Respond to queries from case owners and escalate complex issues to management.
Ensure compliance with ICH, EMA, and FDA guidelines, GPVP, and GCP standards.
Participate in internal project meetings, audits, and inspections.
Document review findings and case comments in the medical review workflow.
Stay updated on product safety profiles and therapeutic area knowledge.
Required Skills & Qualifications
Degree in Medicine (MD or MBBS).
Minimum 3 years of experience in Pharmacovigilance and Drug Safety.
Strong knowledge of ICH, GPVP, and FDA guidelines.
Expertise in MedDRA coding and adverse event reporting.
Excellent organizational, mentoring, and team management skills.
Fluent in English with strong written and verbal communication skills.
Perks & Benefits
Competitive salary and performance-based benefits.
Opportunity to lead global PV and risk management initiatives.
Work with a reputed pharmaceutical consulting company.
Professional development and training programs.
Company Description
Cencora, a leader in pharmaceutical consulting and drug safety, is committed to creating healthier futures through innovative healthcare solutions. With a global footprint and expertise in pharmacovigilance, clinical research, and regulatory affairs, Cencora supports life sciences companies in achieving quality and compliance excellence.
Work Mode: On-site (Noida, India)
Salary/Compensation: Not specified in the description.
Call-to-Action
If you are an experienced Drug Safety Physician ready to take on a leadership role in pharmacovigilance, apply now and join Cencora to make a global healthcare impact.
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