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Assoc Medical Safety Dir

3+ years
Not Disclosed
10 July 8, 2025
Job Description
Job Type: Full Time 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 – Pharmacovigilance

Location: Kochi, India
Job Type: Full-Time
Work Mode: On-site (additional locations available)


Job Summary:

IQVIA is hiring an experienced Associate Medical Safety Director to lead critical pharmacovigilance activities including medical review of safety data, regulatory submissions, and benefit-risk assessments. This role plays a central part in ensuring drug safety oversight across global clinical trials and post-marketing safety services. Ideal for licensed physicians with a strong foundation in clinical practice and drug safety.


Key Responsibilities:

  • Perform medical review and clarification of trial-related adverse events (AEs) and ADRs

  • Review and edit Analyses of Similar Events (AOSE) in compliance with regulatory timelines

  • Consult pharmacovigilance case processing teams on safety-related issues

  • Conduct aggregate safety data reviews and oversee product safety profiles

  • Review clinical data (AEs, medical history, medications) for medical accuracy and coding

  • Participate in client meetings and safety review discussions

  • Provide medical input into IND annual reports, PBRERs, PSURs, and DSURs

  • Contribute to Risk Management Plans (RMPs) and Risk Evaluation & Mitigation Strategies (REMS)

  • Attend DSMB and SMC meetings, offering medical safety evaluation

  • Support label development and safety updates for regulatory submissions

  • Perform safety reviews of protocols, CRFs, and IBs for safety data capture

  • Serve as global safety physician or backup for assigned projects

  • Ensure timely medical safety deliverables per project requirements

  • Stay informed about evolving pharmacovigilance regulations and best practices


Required Skills & Qualifications:

  • Medical degree from an accredited medical school

  • Minimum 3 years of clinical practice and 2 years of pharma/industry experience (or equivalent)

  • Strong knowledge of ICH-GCP, PV regulations, and clinical trial processes

  • Experience with case processing, safety signal detection, and regulatory documentation

  • Effective communication and medical writing skills

  • Valid medical license preferred

  • Ability to manage multiple projects and regulatory timelines

  • Strong collaboration and consultation skills across global teams


Perks & Benefits:

  • Global exposure to pharmacovigilance operations

  • Opportunity to contribute to drug safety on a large scale

  • Access to cutting-edge clinical research platforms

  • Collaborative environment with industry leaders

  • Career advancement opportunities in medical safety


Company Overview:

IQVIA is a global leader in clinical research, healthcare analytics, and pharmacovigilance services. With a mission to accelerate the development of innovative medical solutions, IQVIA connects data, technology, and human expertise to transform healthcare outcomes.


Work Mode:

On-site – Kochi, India (with availability in additional locations)


Call-to-Action:

Are you a licensed physician ready to drive global drug safety? Apply now to lead pharmacovigilance excellence as an Associate Medical Safety Director with IQVIA.