Associate Medical Safety Director
Location: Bengaluru, India
Work Model: Hybrid
Employment Type: Full-Time
Job Overview
IQVIA is seeking an experienced Associate Medical Safety Director to provide expert medical oversight across pharmacovigilance and clinical safety operations. This role supports the full spectrum of Medical Safety activities for assigned clinical trials and standalone safety projects, working under appropriate guidance from senior medical safety leadership. The position requires in-depth clinical knowledge, strong analytical capabilities, and the ability to ensure compliance with regulatory safety requirements.
Key Responsibilities
Medical Review & Safety Oversight
Perform comprehensive medical review of trial-related Adverse Events (AEs) and post-marketing Adverse Drug Reactions (ADRs), including narrative quality, coding, causality, expectedness, seriousness, and company assessment.
Compose, review, and approve Analyses of Similar Events (AOSE) for expedited reporting requirements.
Serve as a medical consultant to pharmacovigilance case processing teams and internal stakeholders.
Conduct aggregate reviews of clinical and safety data to monitor the benefit-risk profile of assigned products.
Clinical Data Review & Reporting
Review coding of AEs, medical history, concomitant medications, and other medical data listings to ensure accuracy and clinical consistency.
Present safety findings and clinical review insights during client meetings.
Provide medical review and edits for key regulatory documents including:
IND Annual Reports
EU PBRERs and PSURs
DSURs
US Periodic Reports
Risk Management & Label Safety
Contribute medical oversight to the creation and review of Development Risk Management Plans, EU Risk Management Plans, and US REMS.
Support medical oversight for safety-related label development and revisions.
Safety Monitoring & Governance
Participate in Data Safety Monitoring Board (DSMB) activities and Safety Monitoring Committee evaluations.
Provide medical inputs to the Integrated Safety Summary or the safety components of the Common Technical Document (CTD).
Review and approve the Project Safety Plan and Medical Monitoring Plan based on contractual scope.
Conduct Medical Safety review of study protocols, Investigator Drug Brochures (IDBs), and Case Report Forms (CRFs).
Project Leadership & Escalation Support
Act as Global Safety Physician, Assistant, or Back-up for assigned projects as required.
Attend project meetings, client meetings, and medical safety team discussions.
Ensure timely delivery of all medical safety activities according to regulatory and contractual timelines.
Provide medical escalation support for medical information projects and EU Qualified Person for Pharmacovigilance (QPPV) needs.
Offer 24-hour medical support for assigned studies as required.
Maintain up-to-date knowledge of regulatory and medical safety developments.
Required Qualifications & Experience
Education
Medical degree (MD or equivalent) from an accredited and internationally recognized medical school.
Experience
Minimum 3 years of clinical practice experience (e.g., post-graduate medical training).
At least 2 years of experience in the pharmaceutical or healthcare industry in pharmacovigilance, clinical research, medical affairs, or related functions.
Equivalent combinations of clinical training and industry experience will be considered.
Skills & Competencies
Strong understanding of pharmacovigilance regulations, global safety guidelines, and Good Clinical Practice (GCP).
Knowledge of the clinical research lifecycle and pharmaceutical development processes.
Proven ability to manage multiple priorities and meet tight timelines.
Strong analytical skills, flexibility, and initiative in problem-solving.
Excellent communication and interpersonal skills.
Ability to build effective working relationships with cross-functional teams, leadership, and clients.
Valid medical license from the region of residence (preferred).
About IQVIA
IQVIA is a global leader in clinical research, healthcare intelligence, and data-driven technology solutions. Through advanced analytics and scientific expertise, IQVIA supports life sciences organizations in accelerating innovation, enhancing safety monitoring, and improving patient outcomes worldwide.
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