Associate Medical Safety Director – Pharmacovigilance
Location: Kochi, India
Work Mode: Full-Time
Requisition ID: R1479136
Job Overview:
IQVIA is seeking an Associate Medical Safety Director to deliver expert medical oversight in the pharmacovigilance domain. This role involves reviewing safety data from clinical trials and post-marketing settings, managing medical content for regulatory documents, participating in client meetings, and ensuring that products maintain a favorable benefit-risk profile throughout their lifecycle. The position works under the guidance of senior medical safety directors and engages with cross-functional teams on global safety projects.
Key Responsibilities:
Conduct medical review and clarification of AEs and ADRs, including narratives, seriousness, causality, and coding.
Author and review Analyses of Similar Events (AOSE) for expedited cases as per regulatory mandates.
Provide medical input for aggregate safety documents, including PSURs, PBRERs, DSURs, IND Annual Reports, and ad hoc reports.
Evaluate and medically vet clinical data listings including AE coding, past medical history, and concomitant medications.
Participate in safety review meetings, client discussions, and Data Safety Monitoring Boards (DSMBs).
Provide medical safety input to product labeling, risk management strategies, and safety plans.
Contribute to and sign off on Project Safety Plans (PSPs) and Medical Monitoring Plans (MMPs).
Conduct protocol and CRF reviews to ensure appropriate safety content and data capture.
Act as Global or Assistant Safety Physician for assigned projects, providing 24/7 medical support as required.
Maintain awareness of emerging trends and regulatory changes in the safety and pharmacovigilance landscape.
Qualifications:
Medical Degree (MBBS or equivalent) from a recognized and accredited medical institution (mandatory).
Minimum 3 years of clinical practice experience post-graduation (residency/PG counts).
Minimum 2 years in the pharmaceutical/clinical research industry in a safety or clinical capacity.
In-depth knowledge of clinical research regulations, GCP, safety reporting, and pharmacovigilance practices.
Familiarity with safety documents like DSUR, PBRER, RMP, REMS, and CTD components.
Excellent communication skills – verbal and written – with an ability to interact with global teams and regulatory agencies.
Strong analytical skills, time management, and proficiency in safety database tools and MS Office.
Valid medical license is preferred.
Estimated Salary: ₹36,00,000 – ₹52,00,000 per annum (based on experience and market standards)
About IQVIA:
As a global leader in clinical research and health data analytics, IQVIA provides advanced insights and services that accelerate healthcare innovation and improve patient outcomes. Join us and help shape the future of pharmacovigilance.
Apply Now at IQVIA Careers
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