Position: Associate Medical Safety Director
📍 Location: Bengaluru, India (Hybrid)
📍 Additional Location: Ahmedabad, India
🏢 Company: IQVIA
🕒 Employment Type: Full-Time
💼 Job ID: R1497935
About IQVIA
IQVIA is a global leader in clinical research services, commercial insights, and healthcare intelligence for the life sciences industry.
We create intelligent connections to accelerate the development and commercialization of innovative medical treatments — improving patient outcomes and population health worldwide.
🔗 Learn more: https://jobs.iqvia.com
Job Overview
The Associate Medical Safety Director (AMSD) provides medical expertise in pharmacovigilance across assigned trials and standalone safety projects. This role participates in all aspects of medical safety operations with oversight from management or senior medical safety directors.
Key Responsibilities
Medical Review & Oversight
Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing Adverse Drug Reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality, and company summaries.
Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases per regulatory requirements.
Conduct coding review of AEs, past medical history, concomitant medications, or other medical data listings.
Perform aggregate reviews of safety information including clinical data to maintain product safety oversight.
Provide medical review and edits for:
IND Annual Reports
EU PBRERs, EU PSURs, EU DSURs, US Periodic Reports
Development Risk Management Plans (EU RMP, US REMS)
Provide medical oversight for label development, review, and change.
Support and attend Data Safety Monitoring Board Meetings and Safety Monitoring Committees.
Contribute to Integrated Safety Summaries or Common Technical Documents.
Review and sign off Project Safety Plans and Medical Monitoring Plans.
Perform medical safety review of protocols, Investigative Drug Brochures (IDB), and Case Report Forms (CRFs).
Act as Global Safety Physician, assistant, or backup on projects.
Provide 24-hour medical support on assigned projects.
Stakeholder & Project Management
Represent safety and clinical data findings during client meetings.
Serve as internal consultant to pharmacovigilance case processing teams.
Provide medical escalation support for medical information projects and EU QPPV projects.
Ensure coverage for all medical safety deliverables within regulatory and contractual timelines.
Compliance & Continuous Learning
Maintain awareness of medical-safety regulatory industry developments.
Ensure compliance with applicable regulations, guidelines, and company policies.
Qualifications & Requirements
Education & Licensure
Medical degree from an accredited and internationally recognized medical school.
Valid medical license (or equivalent) in the country/region preferred.
Experience
3 years of clinical practice (e.g., graduate medical training).
2 additional years in the pharmaceutical or associated industry, or equivalent combination of education, training, and experience.
Knowledge & Skills
Knowledge of federal and local regulations related to clinical research, safety, and good clinical practice.
Knowledge of clinical trials and pharmaceutical research processes.
Ability to manage priorities, meet deadlines, and provide consultation across multiple assignments.
Strong initiative, flexibility, and ability to establish effective working relationships with coworkers, managers, and clients.
Why Join IQVIA?
🌍 Work with a global leader in clinical research and healthcare intelligence.
💡 Contribute to pharmacovigilance and patient safety on a global scale.
🤝 Hybrid work environment offering flexibility and collaboration.
🌐 Opportunities for career growth and professional development.
📩 Apply Now: IQVIA Careers – Associate Medical Safety Director
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