Job Title:
Associate Director, Medical Safety
Job Location:
Bengaluru, India
Company:
IQVIA
Job ID:
R1474801
Job Type:
Full-Time
Role Overview:
The Associate Director of Medical Safety provides medical expertise in pharmacovigilance services, ensuring regulatory compliance and safety assessment across clinical trials and post-marketing activities. This role includes medical reviews, project oversight, regulatory submissions, and leadership responsibilities for managing a team of physicians.
Essential Functions:
Medical Safety Review:
Review and clarify adverse events (AEs) and post-marketing adverse drug reactions (ADRs), including coding, expectedness, seriousness, causality, and company summaries.
Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases.
Provide aggregate reviews of clinical safety data to maintain product safety profiles.
Regulatory Oversight:
Provide medical review and edits for regulatory reports including IND Annual Reports, Periodic Safety Update Reports (PSUR), Risk Management Plans, and Drug Safety Reports.
Ensure compliance with regulatory standards for clinical trial protocols and Investigational Drug Brochures (IDB).
Attend Data Safety Monitoring Board (DSMB) and Safety Monitoring Committees for medical oversight.
Leadership & Team Management:
Line manage a team of regional physicians ensuring project delivery and professional development.
Hold bi-monthly meetings with direct reports to discuss project status, timelines, training, and career development.
Contribute to service line growth and strategy through participation in global medical safety management.
Client & Stakeholder Communication:
Represent medical safety findings during client meetings and discussions.
Prepare for bid defense meetings, contributing to Requests for Proposal (RFPs).
Serve as a Subject Matter Expert (SME) during internal and external cross-functional project meetings.
Medical Support & Escalation:
Provide 24-hour medical support as required for assigned projects.
Offer medical escalation support for pharmacovigilance projects and regulatory agencies.
Qualifications:
Education:
Medical degree from an accredited and internationally recognized medical school.
Experience:
At least 3 years of clinical practice experience and 2 additional years in the pharmaceutical or associated industry, or an equivalent combination of education, training, and experience.
Skills & Knowledge:
Knowledge of federal and local regulations pertaining to clinical research and pharmacovigilance.
Strong leadership, motivational, and influencing skills.
Proven ability to manage multiple projects and priorities.
Excellent verbal and written communication, presentation, and negotiation skills.
Preferred Qualifications:
A valid medical license or equivalent from the country or region of employment.
Application Links:
Apply Now:
IQVIA Career Portal
About IQVIA:
IQVIA is a global provider of clinical research services, commercial insights, and healthcare intelligence. The company accelerates the development and commercialization of innovative medical treatments, improving patient outcomes worldwide.
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