Manager – Drug Safety Physician
Location: Noida, India
Company: Cencora (PharmaLex India Pvt. Ltd.)
Function: Pharmacovigilance / Drug Safety (Consulting)
Work Mode: On-site / Full-time
Experience Required: Minimum 3 years in Pharmacovigilance & Drug Safety
Salary / Compensation: Not disclosed (competitive; as per industry standards)
Job ID: R2513026 | Posted: July 21, 2025
Job Summary (Pharma/PV focused)
Cencora is seeking a Manager – Drug Safety Physician to lead medical review and expert assessment of ICSRs, periodic safety deliverables (PSUR/PBRER), Risk Management Plans (RMPs) and support signal detection for global products. You will ensure full compliance with GPvP, ICH-GCP, EMA/ICH guidelines while mentoring PV associates, driving quality, and acting as a key medical contact during audits, inspections and cross-functional safety governance.
Key Responsibilities
Perform end-to-end medical review of ICSRs (clinical & post-marketing): seriousness, causality, expectedness, MedDRA coding, narratives & Company Clinical Comment.
Respond to case owner queries in the safety database and ensure timely case closure.
Screen and medically triage scientific literature; classify safety-relevant publications.
Author/review PSURs/PBRERs, RMPs, DSUR inputs and other aggregate safety documents.
Collaborate on signal detection strategies and participate in signal evaluation activities.
Maintain strong working knowledge of GVP, GCP, ICH, EMA guidelines and implement best practices.
Train and mentor PV associates on case processing conventions and medical evaluations.
Participate in internal/external audits & inspections; ensure inspection readiness.
Liaise with global PV teams to maintain robust benefit–risk profiles across therapeutic areas.
Ensure accurate documentation, compliance with SOPs/WIs, and on-time safety submissions.
Required Skills & Qualifications
Degree in Medicine (MBBS/MD or equivalent); PG degree is an advantage.
≥3 years of proven Pharmacovigilance / Drug Safety experience.
Hands-on expertise with:
MedDRA coding, ICSR medical review, narrative writing
GVP, ICH-GCP, EMA/ICH regulations
Aggregate safety reporting (PSUR/PBRER, RMP) & signal detection
Strong understanding of benefit–risk assessment and regulatory expectations.
Excellent written & verbal communication and stakeholder management skills.
Ability to lead, mentor, and work under pressure in a fast-paced PV environment.
Perks & Benefits (Indicative – per Cencora local policy)
Competitive, industry-aligned compensation package (not disclosed).
Global, purpose-driven organization focused on healthcare impact.
Continuous learning, mentorship, and cross-functional exposure.
Inclusive, equal-opportunity employer with strong compliance culture.
Company Snapshot (SEO-rich)
Cencora (inclusive of PharmaLex India Pvt. Ltd.) is a global leader in pharmacovigilance, regulatory affairs, and drug development consulting, empowering biopharma companies to deliver safer, compliant therapies worldwide. With a deep focus on GPvP, ICH-GCP, EMA/ICH compliance and end-to-end safety operations, Cencora enables clients to navigate complex global regulations and protect patient safety at scale.
Work Mode
On-site, Noida (Full-time).
Call-to-Action
Ready to lead medical safety in a global, compliance-driven environment? Apply now and help Cencora advance patient safety and benefit–risk management worldwide.
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