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Sr Medical Safety Advisor

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

Sr Medical Safety Advisor
Location: Thāne, India
Job ID: R1479149
Employment Type: Full-Time


Job Overview:
As a Senior Medical Safety Advisor, you will play a crucial role in evaluating safety data from diverse sources within the pharmacovigilance process. You will assess the medical relevance of serious adverse event (SAE) reports within the broader safety profile of a product and its therapeutic class. This role also involves technical leadership, matrix management, and collaboration in preparing aggregate reports, while overseeing safety surveillance for specific products.


Essential Functions:

  • Conduct medical review and clarification of AEs and ADRs including narrative content, coding, seriousness, causality, and summaries

  • Review and edit AOSE (Analyses of Similar Events) for expedited case processing

  • Vet clinical data listings for AEs, SAEs, PMH, and concomitant medications

  • Serve as a medical consultant to case processing teams

  • Perform medical review of study protocols, IBs, and CRFs

  • Conduct aggregate reviews of safety information (DSUR, RMP, PBRER, literature, observational data)

  • Ensure compliance and quality service delivery within regulatory timelines

  • Provide pharmacovigilance guidance and lead single-case assessment teams

  • Maintain and update RSI lists, watchlists, and other safety documentation

  • Drive team training, audits, and product transition initiatives

  • Review and approve Project Safety Plans and Medical Monitoring Plans

  • Represent the safety team in internal and external meetings

  • Act as Lead or Backup Safety Physician on projects

  • Provide 24/7 medical support as required

  • Engage in signal detection strategies and industry trend awareness


Qualifications:

  • Education: Medical degree from an accredited international medical school (mandatory)

  • Experience:

    • Minimum 3 years in clinical practice post-medical degree (residency counts) – Required

    • At least 2 years in the pharmaceutical industry – Preferred

  • Knowledge & Skills:

    • Sound clinical knowledge and strong understanding of pharmacovigilance (ICSRs & aggregate reports)

    • Familiarity with global regulatory requirements (GCP, ICH)

    • Proficiency with safety databases and Microsoft Office tools

    • Strong verbal and written communication skills

    • Valid medical license (preferred)

    • Excellent interpersonal and stakeholder engagement abilities


About IQVIA:
IQVIA is a global leader in advanced analytics, technology solutions, and clinical research services to the life sciences industry. We are committed to connecting insights and accelerating innovation to improve healthcare outcomes worldwide. Learn more at
IQVIA Careers.