Senior Medical Safety Advisor – India
Department: Medical
Location: Bengaluru, Karnataka
Job Type: Full-Time
End Date to Apply: 31st December 2025
Job Overview:
Provide medical expertise in evaluating safety data from various sources as part of the pharmacovigilance process. Determine the medical and scientific relevance of serious adverse event reports in the context of the product's safety profile. This position also plays a senior technical leadership role, participating in matrix management activities and supporting the evaluation of safety issues, preparation of aggregate reports, and surveillance activities for selected products.
Essential Functions:
Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing Adverse Drug Reactions (ADRs), including narrative content, queries, coding, expectedness, seriousness, causality, and company summaries.
Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate, based on regulatory requirements.
Provide coding review of AEs, SAEs, SADRs, past medical history, concomitant medications, and other medical data listings to verify and medically vet clinical data.
Serve as an internal consultant to pharmacovigilance case processing teams on supported projects.
Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture.
Provide aggregate reviews of safety information, including clinical data, post-marketing, literature reviews, and observational studies to maintain oversight of a product's safety profile (e.g., DSUR, RMP, PBRER, ad hoc regulatory reports).
Ensure service delivery from productivity, compliance, and quality perspectives within regulatory/contracted timelines. Lead and participate in initiatives for the same from a team delivery perspective.
Provide therapeutic area/pharmacovigilance guidance in the context of leading and managing other safety team members in single case assessment.
Update watch lists, lists of expectedness, labeling lists/RSIs, and develop additional capabilities within the team.
Lead, drive, and participate in training activities, product transitions, audit preparation, and knowledge exchange initiatives.
Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope.
Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings.
Act as Lead Safety Physician or provide additional team support/back up on assigned projects.
Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as needed.
Provide 24-hour medical support on assigned projects.
Stay informed about medical safety-regulatory industry developments.
Support and participate in signal detection efforts, such as strategy meetings.
Qualifications:
Medical degree from an accredited and internationally recognized medical school with relevant general medical education.
Three (3) years of experience practicing clinical medicine after the award of the medical degree. Graduate and/or residency training can qualify for clinical practice experience.
Two (2) years of pharma experience (preferred).
In-depth knowledge of medicine.
Knowledge of global, regional, and local clinical research regulatory requirements, including GCP and ICH guidelines.
Knowledge of pharmacovigilance, ICSR, and aggregate reports.
Knowledge of departmental standard operating procedures (SOPs).
Skilled in the use of multiple safety databases.
Proficient in Microsoft Word, Excel, and PowerPoint.
Strong verbal and written communication skills.
Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients, and regulatory agencies.
A valid medical license or equivalent from the country or region where the candidate resides and works (preferred).
About IQVIA:
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
Learn more: IQVIA Careers
Location: Bengaluru, India
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