Role & Responsibilities
• Perform medical review of clinical trial and post-marketing safety cases (AEs, SAEs, ADRs)
• Review and ensure accuracy of narratives, coding, seriousness, expectedness, and causality
• Compose and medically review Analyses of Similar Events (AOSE)
• Provide medical oversight and coding review for AEs, SAEs, concomitant medications, and medical history
• Act as internal medical consultant to pharmacovigilance case processing teams
• Review protocols, Investigator Brochures, CRFs, and safety sections for appropriate data capture
• Conduct aggregate safety reviews (DSUR, RMP, PBRER, ad-hoc regulatory reports)
• Maintain and oversee product safety profiles across lifecycle stages
• Ensure compliance, quality, and timely service delivery as per regulatory and contractual timelines
• Provide guidance and mentorship to safety team members on medical assessments
• Maintain and update safety watch lists, labeling, RSIs, and expectedness documents
• Lead and support training initiatives, audits, inspections, and product transitions
• Review and approve Project Safety Plans and Medical Monitoring Plans
• Represent medical safety findings in internal and client meetings
• Act as Lead Safety Physician or provide backup medical support on assigned projects
• Support medical escalations and EU QPPV-related activities when required
• Provide 24-hour medical safety support on assigned projects (as applicable)
• Participate in signal detection activities and safety strategy discussions
• Stay updated with global pharmacovigilance regulations and industry developments
Qualification
• Medical degree (MBBS or equivalent) from an internationally recognized institution
• Valid medical license (preferred)
Experience
• Minimum 3 years of clinical practice post medical qualification
• Minimum 2 years of experience in pharmacovigilance / pharmaceutical industry (preferred)
• Experience in ICSR review and aggregate safety reporting
Skills
• Strong knowledge of clinical medicine and drug safety
• In-depth understanding of GCP, ICH, and global PV regulations
• Hands-on experience with safety databases and PV systems
• Strong analytical, medical writing, and decision-making skills
• Excellent verbal and written communication skills
• Ability to work independently and within matrix teams
• Proficiency in MS Word, Excel, and PowerPoint
About the Company
• IQVIA is a global leader in clinical research, pharmacovigilance, and healthcare analytics
Unlock refined AI insights.