🏷️ Job Title:
Senior Medical Safety Advisor
Job ID: R1492668
Location: Bengaluru, India (Home-based / Remote)
Employment Type: Full-Time
Job available in additional locations
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🧭 Job Overview
As a Senior Medical Safety Advisor at IQVIA, you will play a senior technical leadership role in evaluating safety data from multiple sources to assess medical and scientific relevance in the context of a product’s safety profile. You'll contribute to signal detection, regulatory reporting, and cross-functional matrix team collaboration, while providing therapeutic expertise and oversight for post-marketing and clinical pharmacovigilance activities.
🔍 Key Responsibilities
📋 Medical Review & Evaluation
Review and clarify:
Clinical trial-related Adverse Events (AEs)
Post-marketing Adverse Drug Reactions (ADRs)
Narrative content, seriousness, causality, expectedness, coding, and company summaries
Compose, edit, and medically review:
Analyses of Similar Events (AOSE) for expedited cases as per regulatory requirements
Conduct coding review of:
AEs, SAEs, SADRs, Past Medical History, Concomitant Medications, and other clinical data listings
Serve as an internal medical consultant to pharmacovigilance case processing teams
📝 Aggregate & Document Review
Conduct aggregate reviews of:
Clinical data
Literature sources
Post-marketing surveillance data
Observational studies
Contribute to authoring or reviewing:
DSUR (Development Safety Update Reports)
RMP (Risk Management Plans)
PBRER (Periodic Benefit-Risk Evaluation Reports)
Ad hoc regulatory reports
🛡️ Safety Oversight & Strategy
Perform medical review of:
Study Protocols
Investigator Brochures (IBs)
Case Report Forms (CRFs) for safety content and data capture
Ensure:
Timely service delivery with high compliance and quality
Updates to safety tracking lists like watchlists, RSI (Reference Safety Information), and expectedness lists
📊 Leadership & Team Support
Lead and participate in:
Training activities, audit preparations, and knowledge-sharing sessions
Product transitions and team-wide process improvement initiatives
Guide and support team members in single case assessments and therapeutic decision-making
Review and sign off on:
Project Safety Plans
Medical Monitoring Plans
🤝 Client & Cross-functional Engagement
Attend and contribute to:
Project meetings, medical safety team meetings, and client meetings
Act as:
Lead Safety Physician or back-up/secondary physician on assigned projects
Provide 24/7 medical support as needed
Offer medical escalation support for:
Medical information inquiries
EU QPPV projects
📈 Signal Detection & Regulatory Vigilance
Participate in signal detection strategy discussions
Stay informed on regulatory, safety, and industry trends
🎓 Qualifications
🩺 Education
Medical Degree from an accredited and internationally recognized medical school (Required)
Valid Medical License from home country/region (Preferred)
💼 Experience
Minimum 3 years clinical practice post-MD (Residency/Graduate medical training accepted)
2+ years in pharmaceutical or clinical research industry (Preferred)
📘 Knowledge & Skills
Strong clinical medicine background and therapeutic area expertise
In-depth knowledge of:
Pharmacovigilance processes (ICSRs, aggregate reports)
Good Clinical Practice (GCP) and ICH Guidelines
Experience with:
Safety databases and regulatory documentation
Tools like Microsoft Word, Excel, PowerPoint
Strong verbal and written communication skills
Ability to manage cross-functional relationships and stakeholder communication
🏢 About IQVIA
IQVIA is a global leader in clinical research, real-world data analytics, and pharmaceutical consulting. The company empowers healthcare organizations with intelligent insights and technologies to improve patient outcomes and accelerate innovation in medical development.
🔗 Learn more: https://jobs.iqvia.com
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