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Assoc Medical Safety Dir

3-5 years years
Not Disclosed
10 Aug. 29, 2025
Job Description
Job Type: Full Time Education: Medical degree from an internationally recognized medical school 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

Position Title:

Associate Medical Safety Director

Location:

Kochi, India
(Also available in additional locations)

Job Type:

Full-Time | Onsite/Hybrid
Job ID: R1479136


Job Overview:

As an Associate Medical Safety Director, you will provide high-level medical expertise across pharmacovigilance services and safety-related clinical trials. This role supports medical safety operations across assigned trials and standalone safety projects, with oversight from senior leadership.


Key Responsibilities:

Case Review & Safety Analysis

  • Conduct medical review and clarification of:

    • Clinical trial-related Adverse Events (AEs)

    • Post-marketing Adverse Drug Reactions (ADRs)

  • Evaluate case narratives, causality, seriousness, expectedness, and coding (e.g., MedDRA)

  • Compose and review Analyses of Similar Events (AOSE) for expedited regulatory reporting

Internal & External Consultation

  • Serve as internal consultant to pharmacovigilance case processing teams

  • Represent Medical Safety findings in client meetings

  • Provide medical review of:

    • Project Safety Plans

    • Medical Monitoring Plans

    • Protocols

    • Case Report Forms (CRFs)

    • Investigational Drug Brochures (IDBs)

Aggregate Reporting & Risk Management

  • Conduct safety profile oversight using:

    • Clinical trial data

    • Post-marketing surveillance

    • Literature reviews

  • Contribute medical content for:

    • Annual Safety Reports (e.g., IND, DSUR, PBRER, PSUR, DSUR, etc.)

    • Risk Management Plans (RMPs)

    • Risk Evaluation and Mitigation Strategies (REMS)

    • Integrated Safety Summaries (ISS)

    • Common Technical Documents (CTDs)

    • Drug Safety Reports and Benefit-Risk Assessments

Oversight & Escalation Support

  • Act as Global Safety Physician or assistant/back-up as assigned

  • Support:

    • Medical Information escalations

    • EU Qualified Persons for Pharmacovigilance (QPPV)

    • Data Safety Monitoring Boards (DSMBs) and Safety Monitoring Committees

  • Provide 24-hour medical coverage for assigned studies when required

  • Stay updated on evolving medical safety regulatory requirements


Qualifications:

Criteria Details
Education Medical degree from an internationally recognized medical school (Required)
Clinical Experience At least 3 years of clinical practice (e.g., residency or graduate medical training)
Pharma Experience Minimum 2 years in pharmaceutical or related industry roles (or equivalent combination of experience and education)
Licensure Valid medical license in country/region of residence (Preferred)

Skills & Competencies:

  • In-depth knowledge of GCP, ICH, and global pharmacovigilance regulations

  • Strong understanding of:

    • Clinical trials

    • Drug development and safety monitoring processes

  • Expertise in reviewing clinical data (labs, narratives, coding)

  • Excellent written and verbal communication skills

  • Ability to manage multiple priorities, meet deadlines, and handle complex safety reviews

  • Collaborative, consultative, and detail-oriented approach

  • Proficient in working with cross-functional teams, clients, and regulatory bodies


About IQVIA:

IQVIA is a global leader in clinical research, real-world evidence, data analytics, and technology services, enabling smarter healthcare decisions and improving patient outcomes.

🌐 Learn more: https://jobs.iqvia.com