Associate Medical Safety Director – Pharmacovigilance
Location: Kochi, India
Work Mode: Full-Time
Requisition ID: R1474799
Job Overview:
IQVIA is hiring an Associate Medical Safety Director to provide end-to-end medical expertise in pharmacovigilance activities, supporting both clinical trials and post-marketing safety assessments. The role involves medical review, benefit-risk analysis, regulatory report contributions, and strategic oversight in safety-related deliverables. Working under the guidance of senior medical safety leadership, this position requires experience in safety data evaluation, regulatory reporting, and stakeholder management across global projects.
Key Responsibilities:
Review and clarify Adverse Events (AEs) and Adverse Drug Reactions (ADRs) in clinical and post-marketing settings.
Compose and review Analyses of Similar Events (AOSE) for expedited cases.
Provide medical consultation to pharmacovigilance case processing teams.
Conduct aggregate reviews to oversee product safety profiles.
Perform medical vetting of AEs, medical history, and concomitant medications in clinical datasets.
Represent the safety team during client meetings and regulatory interactions.
Review and edit key safety documents:
IND Annual Reports
EU PSURs, PBRERs, DSURs
Risk Management Plans (RMPs), REMS
Integrated Safety Summaries (ISS), CTDs
Provide labeling support and safety evaluations for product labeling changes.
Participate in Safety Monitoring Committees (SMCs) and Data Safety Monitoring Boards (DSMBs).
Contribute to Medical Monitoring Plans (MMPs) and Project Safety Plans (PSPs).
Act as Global/Assistant/Back-up Safety Physician for assigned projects.
Offer 24/7 medical coverage on applicable studies and maintain awareness of global PV regulatory updates.
Support medical escalations and provide consultative input for medical information and QPPV projects.
Required Qualifications:
Medical Degree (MBBS or equivalent) from a recognized and accredited institution (mandatory).
Minimum 3 years of clinical practice experience (including PG/residency).
At least 2 years of experience in the pharmaceutical/clinical research industry in any capacity.
Strong understanding of clinical research regulations, ICH, GCP, and pharmacovigilance guidelines.
Familiarity with regulatory documentation, labeling, and safety surveillance practices.
Ability to multi-task, prioritize timelines, and maintain high accuracy in medical content.
Effective communication skills, both verbal and written.
Adept at stakeholder engagement and cross-functional teamwork.
Valid medical license preferred.
Estimated Salary: ₹38,00,000 – ₹54,00,000 per annum (based on industry standards and candidate experience)
About IQVIA:
IQVIA is a global leader in data-driven healthcare solutions. We empower clients through advanced analytics, technology, and deep domain expertise to bring better medical innovations to life. Join our expert medical safety team and help shape the future of patient safety.
Apply Now at IQVIA Careers
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