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Senior Specialist, Pharmacovigilance, Epidemiology & Risk Management

4+ years
Not Disclosed
10 July 28, 2025
Job Description
Job Type: Remote Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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

 

Senior Specialist, Pharmacovigilance, Epidemiology & Risk Management

Location: Noida, India (Remote Possible)
Posted on: July 21, 2025
Company: Cencora (PharmaLex India Pvt Ltd)
Job Type: Full-Time, Permanent


Job Summary

Cencora is hiring a Senior Pharmacovigilance Specialist to lead safety data analysis, risk management documentation, and global regulatory interactions. This high-impact remote role is ideal for professionals with 4+ years of experience in pharmacovigilance, signal detection, and regulatory writing including PBRERs, PSURs, RMPs, and PRAC responses. Contribute to safer drug outcomes while shaping global health solutions.


Key Responsibilities

  • Prepare and respond to PRAC reports and authority requests

  • Conduct signal detection, safety data analysis, and benefit-risk assessments

  • Write, review, and implement SOPs, WIs, and training materials

  • Design and prepare PBRER, PSUR, RMP, PADER, and ACO documents

  • Develop client-specific PV solutions, ensuring full compliance

  • Manage and communicate project status with clients

  • Participate in audits and inspections, defend processes, and close actions

  • Report and resolve performance deviations from target KPIs

  • Maintain strong relationships with clients, authorities, and partners

  • Collaborate on PV tool and process development


Required Skills & Qualifications

  • Minimum 4 years’ experience in pharmacovigilance and risk management

  • Medical, pharmaceutical, or life sciences background preferred

  • Expertise in regulatory writing: PBRER, PSUR, RMP, PADER, ACO

  • Strong experience with PRAC responses and authority communications

  • Proficient in writing and reviewing SOPs and training materials

  • Strong interpersonal, analytical, and communication skills

  • Client-facing experience and audit handling capabilities


Perks & Benefits

  • Remote work flexibility

  • Opportunities to lead international pharmacovigilance projects

  • Career advancement in a global pharmaceutical consulting company

  • Inclusive work culture committed to diversity and equality

  • Competitive compensation and benefits aligned with market standards


Company Overview

Cencora (PharmaLex India Pvt Ltd) is a global pharmaceutical leader focused on advancing regulatory compliance, drug safety, and patient outcomes. Backed by a team of healthcare and regulatory experts, Cencora delivers innovative pharmacovigilance and risk management solutions across the life sciences sector.


Work Mode: Remote (India-based)
Experience Level: Senior (4+ Years)


Ready to Impact Global Drug Safety?

Apply now to join Cencora’s global team and make your mark in pharmacovigilance, risk management, and regulatory innovation.

[Apply Now on ThePharmaDaily.com]