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Assoc Medical Safety Dir

3+ years
Not Disclosed
10 May 20, 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
Location: Bengaluru, India
Job ID: R1474799
Employment Type: Full-Time


Job Overview:
As an Associate Medical Safety Director, you will provide expert medical input into pharmacovigilance activities and safety assessments across a range of clinical trials and standalone safety projects. Under the oversight of senior management, you will contribute to trial safety, regulatory reporting, benefit-risk evaluation, and client interactions, ensuring compliance with global safety standards.


Essential Functions:

  • Conduct medical reviews of AEs and ADRs, including narratives, queries, seriousness, causality, and regulatory assessments

  • Draft and review AOSEs for expedited safety cases

  • Serve as a medical advisor to case processing teams on assigned projects

  • Review safety data (clinical, post-marketing) to maintain product safety profiles

  • Provide medical coding review for AEs, PMH, and concomitant medications

  • Present safety findings in client meetings and safety review boards

  • Contribute to regulatory safety reports: IND Annual Reports, PBRERs, DSURs, US Periodic Reports

  • Review and edit Risk Management Plans (EU RMP, US REMS) and drug labels

  • Participate in Safety Monitoring Committees and DSMB meetings

  • Provide input for Integrated Safety Summaries (ISS) and CTDs

  • Contribute to benefit-risk assessments and drug safety evaluations

  • Review and sign off on Project Safety Plans and Medical Monitoring Plans

  • Evaluate protocols, IDBs, and CRFs for safety content and data accuracy

  • Act as Global Safety Physician or designated support on assigned projects

  • Participate in internal, cross-functional, and client-facing project meetings

  • Ensure timely delivery of all medical safety outputs within regulatory timelines

  • Offer medical escalation support for MI and EU QPPV projects

  • Provide 24-hour on-call support for assigned studies as required

  • Stay updated on global regulatory developments in pharmacovigilance


Qualifications:

  • Education: Medical degree from an accredited and recognized international medical school – Required

  • Experience:

    • Minimum 3 years clinical practice (including graduate medical training) – Required

    • At least 2 additional years in the pharmaceutical or related industry – Required

  • Knowledge & Skills:

    • Strong understanding of global clinical research regulations and GCP

    • Familiarity with the end-to-end pharmaceutical research and safety processes

    • Capable of setting priorities, meeting deadlines, and working independently

    • Effective communication and consultation skills across assignments

    • Collaborative approach to working with diverse stakeholders

    • Valid medical license – Preferred


About IQVIA:
IQVIA is a global leader in healthcare intelligence, providing advanced analytics, technology solutions, and clinical research services. Our mission is to help life sciences companies accelerate innovation and improve patient outcomes. Discover more at
IQVIA Careers.