Associate Medical Safety Director – Pharmacovigilance
Location: Bengaluru, India
Employment Type: Full-time
Work Mode: Home-based (Remote)
Job Reference ID: R1514647
Job Summary
The Associate Medical Safety Director plays a critical leadership role within the pharmacovigilance function, providing advanced medical expertise for the evaluation, interpretation, and oversight of safety data across clinical development and post-marketing activities. This position is responsible for assessing the medical and scientific relevance of serious adverse events, maintaining product safety profiles, and supporting regulatory compliance across global safety operations. The role also functions as a senior technical leader, contributing to matrix management, safety surveillance strategies, and aggregate safety reporting.
Key Responsibilities
Perform comprehensive medical review of clinical trial and post-marketing adverse events (AEs, SAEs, ADRs), including narratives, coding, seriousness, causality, expectedness, and medical summaries
Prepare, review, and medically approve Analyses of Similar Events (AOSE) for expedited regulatory submissions
Provide medical oversight and validation of clinical safety data, including medical history, concomitant medications, and coding outputs
Act as a medical safety consultant to pharmacovigilance case processing and safety surveillance teams
Conduct medical safety review of study protocols, Investigator’s Brochures, Case Report Forms (CRFs), and related clinical documents
Lead and contribute to aggregate safety evaluations such as DSURs, PBRERs, RMPs, signal assessments, and ad hoc regulatory reports
Ensure compliance with global regulatory timelines, quality standards, and contractual obligations
Support safety surveillance activities, including watch lists, expectedness assessments, labeling reviews, and risk mitigation strategies
Lead and participate in training initiatives, audit readiness activities, product transitions, and cross-functional knowledge-sharing
Review and approve Project Safety Plans and Medical Monitoring Plans as per contractual scope
Represent medical safety expertise in internal and client-facing meetings, including safety governance forums
Serve as Lead Safety Physician or provide backup medical safety coverage for assigned projects, including 24-hour medical support as required
Support signal detection and benefit-risk evaluation activities
Maintain up-to-date knowledge of global pharmacovigilance regulations, medical safety 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 medical degree (residency or postgraduate training may be considered)
Minimum 2 years of experience in the pharmaceutical industry, pharmacovigilance, clinical research, or medical safety (preferred)
Strong working knowledge of pharmacovigilance processes, including ICSR management and aggregate safety reporting
In-depth understanding of global regulatory requirements, including GCP, ICH guidelines, and post-marketing safety obligations
Experience using global safety databases and medical review platforms
Proficiency in Microsoft Word, Excel, and PowerPoint
Excellent written and verbal communication skills
Demonstrated ability to work effectively in matrix environments and collaborate with cross-functional and global teams
Valid medical license in the country of residence/work (preferred)
About the Organization
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 solutions, and deep scientific expertise, IQVIA enables the development and commercialization of innovative therapies that improve patient outcomes worldwide.
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