Associate Medical Safety Director – Kochi (Hybrid)
Salary/Compensation: Not mentioned in the job description.
Job Summary
IQVIA is seeking an Associate Medical Safety Director to provide medical expertise in pharmacovigilance and drug safety. This role involves medical review of adverse events, oversight of safety deliverables, risk management, and regulatory submissions. The position requires close collaboration with clinical research and safety teams to ensure the highest quality in safety evaluations and reports.
Key Responsibilities
Perform medical review of trial-related Adverse Events (AEs) and Adverse Drug Reactions (ADRs), including narratives, coding, and causality assessments.
Review and edit Analyses of Similar Events (AOSE) for expedited regulatory cases.
Act as an internal safety consultant for pharmacovigilance case processing teams.
Conduct aggregate safety reviews and maintain oversight of product safety profiles.
Provide medical review of IND Annual Reports, PBRERs, PSURs, DSURs, Risk Management Plans (RMPs), and REMS.
Participate in Safety Monitoring Committees and Data Safety Monitoring Board meetings.
Provide medical oversight for label development and updates.
Review and sign off on Project Safety Plans and Medical Monitoring Plans.
Provide 24-hour medical support for assigned projects.
Ensure compliance with safety regulations, timelines, and global pharmacovigilance standards.
Required Skills & Qualifications
Medical degree (MBBS or equivalent) from an accredited institution.
3+ years of clinical practice experience plus 2+ years in the pharmaceutical industry.
Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, and pharmacovigilance regulations.
Expertise in clinical trials, drug safety evaluations, and benefit-risk assessments.
Valid medical license or equivalent (preferred).
Strong communication, leadership, and consultation skills.
Perks & Benefits
Hybrid work model for flexible work-life balance.
Opportunities to lead global pharmacovigilance projects.
Continuous professional development in drug safety and clinical research.
Collaborative environment with cross-functional teams.
Company Description
IQVIA is a global leader in clinical research, drug safety, and healthcare intelligence. The company empowers life sciences organizations by combining data, technology, and expertise to accelerate the development of innovative medical treatments that improve patient outcomes and population health.
Work Mode: Hybrid – Kochi, India.
Call-to-Action
If you are a qualified physician with a passion for pharmacovigilance and drug safety, apply now for the Associate Medical Safety Director position at IQVIA and advance your career in a global healthcare leader.
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