Job Title: Senior Medical Safety Advisor
📍 Location: Bengaluru, India
🏠 Work Mode: Home-Based
🕓 Employment Type: Full-Time
🔖 Job ID: R1471135
🌍 Additional Locations: Available
Job Overview
The Senior Medical Safety Advisor will provide medical expertise in evaluating safety data from multiple sources within the pharmacovigilance process. This role ensures the medical and scientific assessment of serious adverse event (SAE) reports in the context of the product’s safety profile and related therapeutic areas.
The position also involves technical leadership, matrix management, and collaboration with Post-Marketing Safety Experts and the Safety Surveillance Group, supporting safety signal detection and aggregate report preparation.
Key Responsibilities
🩺 Medical Review & Safety Evaluation
Conduct medical review and clarification of trial-related AEs and post-marketing ADRs, including narratives, coding, seriousness, causality, and summaries.
Compose, edit, and review Analyses of Similar Events (AOSE) for expedited cases per regulatory requirements.
Perform coding review for AEs, SAEs, SADRs, medical history, and concomitant medications.
Serve as an internal medical consultant to PV case processing teams.
Conduct safety reviews of protocols, Investigator’s Brochures, and CRFs for appropriate data capture.
📊 Aggregate Reporting & Signal Management
Review aggregate safety data (clinical, post-marketing, literature, observational studies) for documents such as DSURs, RMPs, PBRERs, and ad-hoc reports.
Support signal detection and participate in safety strategy discussions.
Maintain watch lists, expectedness lists, labeling lists, and RSIs for assigned products.
🧭 Leadership & Oversight
Lead and mentor safety team members in single case assessment.
Ensure service delivery within productivity, compliance, and quality standards.
Lead training sessions, product transitions, audit preparation, and knowledge-sharing initiatives.
Review and sign-off on Project Safety Plans and Medical Monitoring Plans.
🤝 Collaboration & Client Engagement
Attend project and client meetings, representing medical safety and clinical data insights.
Act as Lead Safety Physician or backup as assigned.
Provide medical escalation support for Medical Information and EU QPPV projects.
Offer 24-hour medical support as needed.
🔄 Compliance & Continuous Learning
Stay updated with industry regulations, GCP, ICH, and evolving safety requirements.
Maintain awareness of global PV guidelines and participate in ongoing improvement initiatives.
Qualifications & Requirements
🎓 Education:
Medical Degree (MD/MBBS) from an accredited and internationally recognized medical school (Required)
Valid medical license or equivalent in country/region of residence (Preferred)
💼 Experience:
3 years practicing clinical medicine post-degree (Residency training may qualify)
2 years pharmaceutical industry experience (Preferred)
🧠 Knowledge & Skills:
Strong foundation in Medicine and Pharmacovigilance (ICSR, Aggregate Reports).
Deep understanding of GCP, ICH Guidelines, and global regulatory requirements.
Proficient in Safety Databases, Microsoft Word, Excel, and PowerPoint.
Excellent written and verbal communication skills.
Strong ability to collaborate across teams, clients, and regulatory bodies.
About IQVIA
IQVIA is a global leader in clinical research services, commercial insights, and healthcare intelligence. Through data, technology, and expertise, IQVIA accelerates the development and commercialization of innovative therapies to improve patient outcomes and population health.
🔗 Learn more: https://jobs.iqvia.com
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