Associate Medical Safety Director – Pharmacovigilance
Location: Bengaluru, India
Employment Type: Full-time
Work Model: Home-based / Remote
Job Reference ID: R1514647
Job Overview
The Associate Medical Safety Director is a senior medical leadership role within Pharmacovigilance, responsible for providing expert medical and scientific oversight in the evaluation of safety data across clinical development and post-marketing phases. This role ensures accurate assessment of serious adverse events within the context of product safety profiles and therapeutic areas. The position also contributes strategically to safety surveillance, aggregate reporting, matrix management, and regulatory compliance while serving as a medical authority across cross-functional safety teams.
Key Responsibilities
Conduct comprehensive medical review of clinical trial and post-marketing adverse events, including narratives, coding, seriousness, causality, expectedness, and medical summaries
Prepare, review, and medically approve Analyses of Similar Events (AOSE) for expedited safety reporting in accordance with global regulatory requirements
Provide medical validation of safety data, including adverse events, serious adverse drug reactions, medical history, and concomitant medications
Serve as a medical safety consultant to pharmacovigilance case processing and safety surveillance teams
Perform medical safety reviews of study protocols, Investigator’s Brochures, and Case Report Forms (CRFs) to ensure appropriate safety data capture
Lead and contribute to aggregate safety evaluations, including DSURs, PBRERs, RMPs, signal assessments, and ad hoc regulatory submissions
Ensure delivery of safety services in alignment with regulatory timelines, quality standards, and contractual obligations
Provide therapeutic area expertise and pharmacovigilance guidance to safety team members during case assessment activities
Maintain and update product safety documentation, including watch lists, expectedness assessments, labeling information, and risk signal inventories
Lead and support training programs, audit readiness activities, product transitions, and knowledge-sharing initiatives
Review and approve Project Safety Plans and Medical Monitoring Plans as per contractual scope
Represent medical safety findings in internal governance forums and client meetings
Act as Lead Safety Physician or provide backup medical safety support across assigned projects, including 24-hour medical coverage when required
Support signal detection and benefit-risk evaluation activities
Maintain current knowledge of global medical safety regulations, pharmacovigilance guidelines, and industry best practices
Required Qualifications and Experience
Medical degree (MBBS, MD, or equivalent) from an accredited and internationally recognized medical institution
Minimum 3 years of clinical practice experience following completion of the medical degree (postgraduate training or residency may be considered)
Minimum 2 years of experience in the pharmaceutical industry, pharmacovigilance, clinical research, or medical safety (preferred)
Strong knowledge of pharmacovigilance processes, including ICSR management and aggregate safety reporting
In-depth understanding of global regulatory requirements, including ICH guidelines and Good Clinical Practice (GCP)
Experience working with global safety databases and medical review systems
Proficiency in Microsoft Word, Excel, and PowerPoint
Excellent written and verbal communication skills
Demonstrated ability to collaborate effectively in matrix and cross-functional environments
Valid medical license in the country of residence or practice (preferred)
About the Company
IQVIA is a global leader in clinical research services, healthcare intelligence, and commercial insights for the life sciences and healthcare industries. Through advanced analytics, technology platforms, and scientific expertise, IQVIA supports the development and commercialization of innovative therapies that improve patient outcomes worldwide.
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