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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: R1474799
Location: Kochi, India (Additional locations available)
Employment Type: Full-Time

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🧭 Job Overview

The Associate Medical Safety Director provides medical expertise in pharmacovigilance services, participating in clinical trial and post-marketing safety evaluations. The role includes responsibilities across medical review, regulatory documentation, risk-benefit assessment, and safety oversight for standalone safety projects and clinical trials, under appropriate supervision from senior leaders.


🔍 Key Responsibilities

📝 Medical Review & Safety Evaluation

  • Conduct medical review and clarification of:

    • Trial-related Adverse Events (AEs)

    • Post-marketing Adverse Drug Reactions (ADRs)

    • Narrative content, seriousness, causality, expectedness, and company summaries

  • Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases


📊 Aggregate & Regulatory Reporting

  • Perform aggregate safety data reviews (clinical and post-marketing)

  • Provide medical review and edits for:

    • IND Annual Reports

    • EU PBRER, PSUR, DSUR

    • US Periodic Reports

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

  • Contribute to:

    • Integrated Safety Summaries

    • Common Technical Documents (CTDs)

    • Drug Safety Reports and other benefit-risk assessments


🛡️ Product Safety & Oversight

  • Oversee:

    • Label development, review, and changes

    • Safety content in Protocols, Investigator Drug Brochures (IDBs), and Case Report Forms (CRFs)

  • Serve as:

    • Global Safety Physician or Assistant/Back-up on assigned projects

    • Medical representative at Data Safety Monitoring Board (DSMB) and Safety Monitoring Committees


👥 Collaboration & Communication

  • Attend and contribute to:

    • Internal medical safety team meetings

    • Client meetings and project discussions

  • Review and sign off on:

    • Project Safety Plans

    • Medical Monitoring Plans

  • Support:

    • Medical Information Projects

    • EU QPPV Projects (Qualified Person for Pharmacovigilance)


⏱️ Operational Accountability

  • Ensure coverage for all medical safety deliverables within regulatory and contract timelines

  • Provide 24/7 medical support for assigned projects

  • Stay informed about evolving medical, regulatory, and safety guidelines


🎓 Qualifications

📚 Education

  • Medical Degree from an accredited and internationally recognized medical school (Required)

  • Valid Medical License in country/region of residence (Preferred)

💼 Experience

  • 3 years of clinical practice experience (e.g., graduate medical training)

  • 2 years of experience in the pharmaceutical or related industry in any role

  • OR equivalent combination of education, training, and industry experience

💡 Knowledge & Skills

  • In-depth knowledge of:

    • Clinical trials and the pharmaceutical development process

    • Global and local regulatory requirements (e.g., GCP, ICH)

    • Safety reporting systems and practices

  • Ability to:

    • Prioritize and meet deadlines

    • Provide expert consultation across multiple projects

    • Build and maintain professional relationships with internal and external stakeholders


🏢 About IQVIA

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help healthcare and life sciences clients drive innovation and improve outcomes.

🌐 Learn more: https://jobs.iqvia.com


📩 Interested?

Click here to apply now
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