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Assoc Medical Safety Dir

3+ years
Not Disclosed
10 July 16, 2025
Job Description
Job Type: Full Time Hybrid 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

 

Associate Medical Safety Director – Kochi (Hybrid)

Location: Kochi, India
Job Type: Full-time
Work Mode: Hybrid
Experience Level: Senior (3+ years clinical + 2 years pharma/industry)
Salary Range: Not specified


Job Summary

IQVIA is seeking an experienced Associate Medical Safety Director to join its global safety operations in Kochi. In this senior-level pharmacovigilance role, you'll provide strategic medical oversight and expertise across clinical trials and post-marketing safety activities. You will ensure scientific rigor and regulatory compliance in AE/ADR evaluations, aggregate safety reports, and medical safety planning. This is an excellent opportunity to lead safety signal evaluations and risk management for life-saving therapies.


Key Responsibilities

  • Perform expert-level medical review of AEs and ADRs, including narratives, seriousness, and causality.

  • Medically review Analyses of Similar Events (AOSE) for expedited cases per regulatory needs.

  • Provide ongoing medical consultation to case processing teams and safety operations.

  • Conduct safety data oversight, including coding reviews and clinical data vetting.

  • Review and edit regulatory safety reports (DSUR, PSUR, PBRER, RMPs, etc.).

  • Attend and contribute to client meetings, DSMBs, and Safety Monitoring Committees.

  • Support the development of Project Safety Plans and Medical Monitoring Plans.

  • Act as Global or Backup Safety Physician on assigned projects.

  • Review protocols, IDBs, and CRFs for safety-related content and compliance.

  • Provide 24/7 medical safety support for designated projects when required.

  • Stay updated on evolving global pharmacovigilance regulations and safety science.


Required Skills & Qualifications

  • Medical degree (MBBS, MD, or equivalent) from a recognized institution – Required

  • Minimum 3 years of clinical practice experience plus 2 years in pharmaceutical or CRO roles – Required

  • Strong knowledge of ICH-GCP, PV guidelines, and global regulatory frameworks.

  • Experience with safety document authoring and medical oversight of pharmacovigilance activities.

  • Proficiency in benefit-risk assessment and safety signal evaluation.

  • Familiarity with safety databases and MedDRA coding practices.

  • Excellent communication, scientific writing, and client-facing presentation skills.

  • Valid medical license preferred.


Perks & Benefits

  • Opportunity to work on global drug safety and risk management initiatives.

  • Hybrid work model with flexibility and international collaboration.

  • Access to IQVIA’s world-class training, research tools, and learning platforms.

  • Competitive industry exposure with career growth in medical safety leadership.


Company Overview

IQVIA is a global leader in advanced clinical research services, pharmacovigilance, real-world data analytics, and healthcare technology. IQVIA partners with top pharmaceutical, biotechnology, and life sciences companies to drive evidence-based innovation, ensure regulatory compliance, and improve global health outcomes through data-driven safety solutions.


Work Mode

Hybrid – This role is based in Kochi, India, with flexibility to support global teams remotely.


Call to Action

Are you a clinically trained physician ready to lead safety strategy in the global pharma industry? Apply now to join IQVIA’s growing team of medical safety experts and shape the future of patient safety.