Senior Medical Safety Advisor
📍 Location: Bengaluru, India (Home-based option available)
🕓 Job Type: Full-time
🆔 Job ID: R1471135
🏢 Company: IQVIA
🌍 Job Available In: Additional global locations
Job Summary
The Senior Medical Safety Advisor provides advanced medical and scientific expertise in evaluating safety data across multiple sources as part of IQVIA’s global pharmacovigilance process. The role ensures the clinical relevance and regulatory accuracy of serious adverse event (SAE) reports, supports signal detection activities, and contributes to aggregate safety reporting.
As a senior technical leader, the advisor participates in cross-functional safety evaluations, oversees surveillance activities for assigned products, and guides safety teams on therapeutic area–specific issues.
Key Responsibilities
Medical & Safety Review
Conduct medical review of clinical trial and post-marketing safety data, including AEs, SAEs, and ADRs.
Assess narratives, seriousness, causality, coding, expectedness, and company summaries.
Review and edit Analyses of Similar Events (AOSE) for expedited cases per regulatory requirements.
Verify coding and medical data related to past medical history, concomitant medications, and other case information.
Safety Oversight & Documentation
Perform medical safety review of study protocols, Investigator Brochures, and Case Report Forms (CRFs).
Contribute to aggregate safety reviews (e.g., DSURs, RMPs, PBRERs, and ad hoc reports).
Review and sign off on Project Safety Plans and Medical Monitoring Plans as per contractual scope.
Maintain and update watch lists, reference safety information (RSI), and product labeling documents.
Leadership & Collaboration
Act as Lead Safety Physician or provide support/back-up for assigned projects.
Provide medical escalation and consultation support to pharmacovigilance teams.
Collaborate with the Safety Surveillance Group and Post-Marketing Safety Experts for signal evaluation.
Participate in project meetings and represent medical safety findings to clients and regulatory teams.
Training & Compliance
Lead and conduct training, audit preparation, and knowledge transfer sessions.
Ensure compliance with cGMP, GCP, ICH, and internal SOPs.
Provide 24-hour medical support as required for assigned projects.
Stay updated on regulatory and industry developments in medical safety.
Qualifications & Experience
|
Requirement |
Details |
|---|---|
|
Education |
Medical Degree (MBBS, MD, or equivalent) from an accredited, internationally recognized institution |
|
Experience |
Minimum 3 years clinical practice (Residency or Graduate Training acceptable); 2 years pharmaceutical industry experience preferred |
|
Medical License |
Valid medical license (preferred) |
|
Knowledge Areas |
Medicine, Pharmacovigilance (ICSRs & Aggregate Reports), Global Regulatory Guidelines (GCP, ICH), SOP compliance |
|
Technical Skills |
Proficient in multiple safety databases, Microsoft Word, Excel, PowerPoint |
|
Soft Skills |
Excellent verbal and written communication; strong teamwork and leadership skills |
Key Competencies
Deep understanding of drug safety, risk management, and signal detection
Strong analytical and problem-solving abilities
Excellent regulatory knowledge and attention to detail
Ability to work effectively in cross-functional and global environments
About IQVIA
IQVIA is a leading global provider of clinical research, real-world data, and healthcare intelligence for the life sciences industry. The company connects science, technology, and analytics to accelerate the development and commercialization of innovative therapies that improve patient outcomes and global health.
🔗 Learn more: https://jobs.iqvia.com
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