Manager, Drug Safety Physician – Pharmacovigilance (Noida, India)
Company: Cencora (PharmaLex India Pvt. Ltd.)
Location: Noida, India
Function: Consulting – Pharmacovigilance / Drug Safety
Employment Type: Full-time, On-site
Experience Required: Minimum 8 years in Pharmacovigilance & Drug Safety
Compensation / Salary: Not disclosed in the job description (industry-competitive total rewards package indicated)
Job Summary
Cencora is hiring an experienced Manager, Drug Safety Physician to lead high-impact pharmacovigilance activities from ICSR medical review to signal detection, PSUR/PBRER and RMP authorship. You’ll ensure strict compliance with ICH, EMA and GVP requirements, mentor PV associates, and partner with global safety teams to strengthen patient safety outcomes across multiple therapeutic areas.
Key Responsibilities
Perform medical review and clinical assessment of ICSRs in the safety database (seriousness, MedDRA coding, causality, narratives, clinical comments).
Respond to safety case queries from case owners and ensure timely resolution.
Screen and medically triage safety-relevant scientific literature using internal and external tools (incl. EMA MLM service).
Prepare and review CIOMS I / MedWatch forms and XML outputs.
Lead/participate in signal detection and evaluation activities with global PV teams.
Author/review periodic safety documents: PSURs, PBRERs, and Risk Management Plans (RMPs).
Maintain and apply expert knowledge of GVP, GCP, ICH, EMA guidance and internal SOPs/WIs.
Provide scientific input for literature surveillance and ensure duplicate checks vs EMA MLM.
Train and mentor PV associates on event capture, case processing conventions, and compliance.
Support audits/inspections, CAPA implementation, and continuous process improvement.
Collaborate cross‑functionally and escalate complex case issues to line management as needed.
Required Skills & Qualifications
Degree in Medicine (MBBS/MD). PG degree advantageous.
≥8 years of hands‑on Pharmacovigilance & Drug Safety experience.
Strong command of MedDRA coding, ICH E2A/E2D, EMA/MLM, GVP Modules, and GCP.
Proven experience with ICSR case processing, causality assessment, narratives, SAE reconciliation, and safety database use.
Expertise in signal detection methodologies, PSUR/PBRER, RMP development, and aggregate reporting.
Familiarity with CIOMS / MedWatch, XML submissions, and PV quality systems.
Excellent written & verbal English, stakeholder communication, and cross‑functional collaboration.
Ability to work under pressure, manage competing priorities, and meet regulatory timelines.
Strong training, mentoring, and team leadership capabilities.
Nice-to-Haves
Experience across multiple therapeutic areas.
Prior exposure to corporate PV environments (CRO/Pharma/Consulting).
Participation in audits/inspections (EMA, FDA, MHRA, etc.).
Perks & Benefits (as indicated by company policy; specifics not disclosed)
Competitive compensation package
Medical, Dental & Vision benefits
Company match 401(k) (or local equivalent)
Flexible PTO / Sick time (aligned with local laws)
Inclusive, diverse & growth‑oriented culture
Company Overview (SEO-Rich)
Cencora (including PharmaLex India Pvt. Ltd.) is a global leader in pharmacovigilance, regulatory affairs, and biopharmaceutical consulting, committed to creating healthier futures. By integrating deep drug safety, regulatory compliance, and medical expertise, Cencora partners with life sciences organizations to accelerate safe, compliant therapies to patients worldwide.
Work Mode
On-site | Noida, India | Full-time
Ready to Lead Drug Safety at Scale?
If you’re a physician with 8+ years of PV experience who thrives on rigorous GVP/ICH compliance, complex ICSR medical reviews, signal detection, and aggregate safety reports, apply now and help Cencora elevate global patient safety.
Gujarat :
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Frank Scottile Blvd |Missouri :
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Frankfurt | Harveysburg |Germany :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Netherlands |Remote Australia :
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Sheffield |Oxfordshire :
Witney |Ontario :
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Auckland |New Zealand :
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Manila |Croatia :
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Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
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Japan | Saitama |Tokyo :
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South Africa | Midrand |Nišava District :
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