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.
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