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Associate Medical Safety Director

2 years
Not Disclosed
10 Sept. 8, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/ B.Pharma/ M.Pharma/ Life Sciences 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

🏷️ Job Title:

Associate Medical Safety Director

Job ID: R1497935
Location: Bengaluru, India (Hybrid)
Employment Type: Full-Time
Job Available in Additional Locations

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🧭 Job Overview

As an Associate Medical Safety Director at IQVIA, you will provide medical expertise to pharmacovigilance services, participating in all aspects of medical safety oversight on assigned clinical trials and stand-alone safety projects. This includes reviewing adverse event data, preparing regulatory safety documents, and providing scientific insight to help ensure the safety and integrity of investigational and marketed products.


🔍 Key Responsibilities

📋 Medical Review & Safety Oversight

  • Conduct medical review and clarification of:

    • Clinical trial-related Adverse Events (AEs)

    • Post-marketing Adverse Drug Reactions (ADRs)

    • Narrative content, queries, coding, seriousness, causality, and company summaries

  • Compose, edit, and medically review:

    • Analyses of Similar Events (AOSE) for expedited case reports

  • Provide aggregate safety data review for clinical development programs

  • Review coding for:

    • AEs, Past Medical History, Concomitant Medications, and other medical data listings

  • Medically vet safety-related clinical data and findings


📊 Document & Report Review

  • Provide medical review and input for:

    • IND Annual Reports

    • Periodic Safety Update Reports (PSURs)

    • Development Safety Update Reports (DSURs)

    • EU Periodic Benefit-Risk Evaluation Reports (PBRERs)

    • Development Risk Management Plans (RMPs)

    • US REMS (Risk Evaluation and Mitigation Strategies)

  • Contribute to:

    • Integrated Safety Summaries (ISS)

    • Common Technical Documents (CTDs)

    • Drug Safety Reports

    • Benefit-risk assessments


📑 Medical Safety Planning & Monitoring

  • Review and sign off on:

    • Project Safety Plans

    • Medical Monitoring Plans

  • Conduct safety review of:

    • Study Protocols

    • Investigator’s Brochures (IBs)

    • Case Report Forms (CRFs)

  • Serve as:

    • Global Safety Physician, Assistant, or Backup, as assigned

  • Participate in:

    • Data Safety Monitoring Board (DSMB) meetings

    • Safety Monitoring Committee discussions

    • Project and client meetings related to medical safety


🆘 Escalation & Regulatory Support

  • Provide medical escalation for:

    • Medical information and safety projects

    • EU Qualified Persons for Pharmacovigilance (QPPV) activities

  • Ensure 24-hour medical support availability on assigned projects

  • Stay current on industry developments, regulations, and safety science


📚 Qualifications

🎓 Education

  • Medical Degree from an accredited and internationally recognized medical school

  • Valid medical license (preferred but not mandatory)

💼 Experience

  • Minimum 3 years of clinical practice (e.g., residency or graduate medical training)

  • At least 2 years in the pharmaceutical or associated industry

  • Equivalent combination of education, training, and experience may be considered

📘 Knowledge & Skills

  • In-depth understanding of:

    • Pharmacovigilance regulations (FDA, EMA, ICH, GVP, etc.)

    • Clinical research process and drug development lifecycle

  • Strong:

    • Analytical and prioritization skills

    • Consultation and problem-solving ability

    • Interpersonal and stakeholder engagement skills

    • Flexibility and initiative

  • Ability to work in a matrix environment and meet tight timelines


🏢 About IQVIA

IQVIA is a global leader in clinical research, healthcare analytics, and real-world evidence. We help life sciences companies accelerate drug development and improve health outcomes through intelligent connections between data, technology, and expertise.

🔗 Learn more at: https://jobs.iqvia.com


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