Job Title: Senior Medical Safety Advisor
Location: Bengaluru, India
Job Type: Full-time
Job ID: R1471135
Company Overview:
IQVIA is a global leader in healthcare intelligence, clinical research services, and commercial insights for the life sciences industry. With a mission to improve patient outcomes and population health, IQVIA creates intelligent connections that accelerate the development and commercialization of innovative medical treatments.
Job Description:
The Senior Medical Safety Advisor provides critical medical expertise in evaluating safety data across sources as part of the pharmacovigilance process. The role involves determining the medical and scientific significance of serious adverse events, guiding surveillance strategies, and leading initiatives across safety operations in collaboration with internal and client teams.
Key Responsibilities:
Conduct medical review and clarification of adverse events (AEs) and post-marketing adverse drug reactions (ADRs), including narratives, coding, seriousness, causality, and overall summaries.
Medically review Analyses of Similar Events (AOSE) for expedited regulatory submissions.
Review coding for AEs, SAEs, medical history, and related data to ensure accuracy and consistency.
Provide expert consultation to pharmacovigilance teams regarding safety case processing.
Review safety content in study protocols, Investigator Brochures, and Case Report Forms (CRFs).
Conduct aggregate safety data reviews (e.g., DSUR, RMP, PBRER, ad hoc reports) to maintain product safety oversight.
Ensure productivity, compliance, and quality of safety deliverables per regulatory or contractual timelines.
Lead and support safety team members in safety issue identification and resolution.
Maintain and update expectedness lists, labeling information, RSIs, and watch lists for assigned products.
Lead knowledge exchange, training, audit preparation, and product transition activities.
Review and approve Project Safety Plans and Medical Monitoring Plans per scope.
Represent safety and clinical data findings in meetings with internal teams and external clients.
Serve as Lead Safety Physician or support role on assigned projects, including 24-hour medical support as required.
Provide medical escalation and support for pharmacovigilance-related inquiries.
Participate in signal detection strategy development and implementation.
Stay updated on medical and regulatory developments in safety and pharmacovigilance.
Qualifications:
Medical degree from an internationally recognized medical school (required).
Minimum of 3 years clinical medical practice experience post-medical degree (residency or graduate training counts toward this requirement).
At least 2 years of pharmaceutical industry experience (preferred).
Solid foundation in general medicine and good clinical practice (GCP).
Knowledge of ICSR, aggregate safety reports, pharmacovigilance processes, and regulatory frameworks (ICH, global/local).
Skilled in using safety databases and standard Microsoft Office tools (Word, Excel, PowerPoint).
Strong verbal and written communication skills.
Ability to lead, mentor, and collaborate across teams and with clients.
Valid medical license preferred (from country of residence).
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