Instagram
youtube
Facebook

Manager, Drug Safety Physician

3+ years
Not Disclosed
10 July 24, 2025
Job Description
Job Type: Full Time Education: MBBS/MD or equivalent Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.