Senior Specialist – Pharmacovigilance, Epidemiology & Risk Management (Noida, India)
Job Summary
Cencora (PharmaLex India Pvt. Ltd.) is hiring a Senior Specialist – Pharmacovigilance, Epidemiology & Risk Management in Noida, India (On-site, Full-time). You’ll lead high-impact pharmacovigilance (PV) activities including signal detection/management, PRAC responses, PSUR/PBRER/RMP/PADER/ACO authoring & review, SOP/WI creation, KPI oversight, audits, CAPA, and client-facing PV consulting. This role is perfect for PV professionals with 4+ years’ experience who are confident with global GVP, ICH, MedDRA coding, and regulatory authority interactions.
Salary / Compensation Range: Not disclosed in the description.
Key Responsibilities
Draft and defend responses to PRAC assessment reports and other authority requests/referrals.
Perform signal detection, signal validation and analysis, and advise on risk–benefit impact and regulatory communications.
Write, review, update and implement SOPs, Work Instructions, client specifications, and PV training materials.
Lead/own project(s) or project parts: planning, execution, client communication, and delivery to timelines and KPIs.
Author, review & maintain core PV documents: PBRER, PSUR, RMP, PADER, ACO.
Trigger, investigate and close non-conformities; perform root-cause analysis and drive CAPAs.
Support and defend client audits/inspections (preparation, response, follow-up action plans).
Design and optimize PV processes/tools with Service Line Leads/Heads.
Ensure client satisfaction, compliance (GVP, ICH-GCP, local laws), and high-quality deliverables.
Regularly escalate systemic issues to the Head of PV/Service Line Lead with solution proposals.
Contribute to resource planning, efficiency improvements, and invoicing scope control.
Required Skills & Qualifications
Minimum 4 years’ proven experience in Pharmacovigilance / Drug Safety.
Hands-on in PBRER, PSUR, RMP, PADER, ACO authoring/review.
Experience preparing PRAC responses and handling Health Authority queries.
Strong SOP/WI drafting, PV process design, and training development experience.
Solid understanding of:
EU GVP Modules (esp. Module IX – Signal Management)
ICH E2C(R2), ICH E2D, ICH-GCP, ISO 9001/14155 (as applicable)
Risk Management Plans (RMPs) & Benefit-Risk evaluation frameworks
MedDRA coding, case processing knowledge (ICSR lifecycle oversight is a plus).
Familiarity with PV databases / safety systems (e.g., Oracle Argus, ARISg, or equivalent).
Strong client communication, project management, KPI governance, and audit readiness.
Ability to lead complex PV deliverables, manage CAPA/Deviations, and drive continuous improvement.
Nice-to-Have / Preferred
Prior experience in consulting PV environments.
Exposure to global signal detection tools, EVDAS, E2B(R3).
Experience in process automation / analytics for PV KPIs.
Knowledge of quality management systems and inspection readiness programs.
Perks & Benefits (per company policy & local market practice)
Competitive full-time package (exact range not disclosed).
Career growth in a global healthcare & consulting leader.
Training & development opportunities.
Inclusive, EEO-compliant workplace committed to diversity & accessibility.
About Cencora (PharmaLex India Pvt. Ltd.)
Cencora is a global healthcare leader committed to creating healthier futures. Through its affiliate PharmaLex India, it delivers end-to-end pharmacovigilance, regulatory, and compliance solutions to pharma, biotech, and med-tech clients worldwide—ensuring quality, safety, and regulatory excellence across the product lifecycle.
Work Mode
On-site | Noida, India | Full-time
Apply Now
Ready to lead complex pharmacovigilance, risk management, and signal detection programs for global clients? Apply today and help Cencora deliver safer therapies to patients worldwide.
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