Job Title: Associate Director, Medical Safety
Location: Bengaluru, India
Job ID: R1474800
Job Type: Full-time
Job Overview:
As an Associate Director, Medical Safety, you will provide strategic medical expertise across pharmacovigilance services, ensuring robust safety oversight on clinical trials and standalone safety projects. This role entails both hands-on medical review activities and people leadership responsibilities, including regional team management and cross-functional collaboration.
Key Responsibilities:
Medical Safety Operations:
Conduct detailed medical reviews of trial-related Adverse Events (AEs) and post-marketing Adverse Drug Reactions (ADRs).
Author and review Analyses of Similar Events (AOSE) as required.
Provide expert guidance to pharmacovigilance case processing teams.
Review aggregate clinical safety data to monitor and manage product safety profiles.
Verify AE coding, concomitant medication listings, and clinical data entries for accuracy.
Deliver safety insights during client-facing meetings.
Medical Content Review:
Review and edit regulatory documents: IND Annual Reports, EU PSURs, DSURs, US Periodic Reports, Risk Management Plans (RMPs), REMS, and Development Risk Management Plans.
Oversee safety content in labeling and label change requests.
Participate in Data Safety Monitoring Boards (DSMBs) and Safety Monitoring Committees (SMCs).
Contribute to Integrated Safety Summaries (ISS) and Drug Safety Reports.
Project & Protocol Oversight:
Approve Project Safety Plans and Medical Monitoring Plans.
Review safety components in clinical protocols, Case Report Forms (CRFs), and Investigative Drug Brochures (IDBs).
Serve as Global Safety Physician or support lead roles on assigned projects.
Ensure timely delivery of all medical safety deliverables per contractual and regulatory standards.
Leadership & Management:
Line manage and support regional physicians; provide mentorship, development plans, and performance oversight.
Represent global medical safety at internal and external stakeholder meetings.
Facilitate effective communication across leadership and teams.
Ensure team engagement and drive strategic objectives.
Business Support & Client Interaction:
Lead or contribute to bid defenses, RFIs, and RFPs.
Interface with Business Development to assess feasibility of proposals.
Represent IQVIA in cross-functional and customer-facing meetings.
Required Qualifications:
Education: Medical Degree (MBBS, MD, or equivalent) from an accredited and recognized institution.
Experience:
Minimum 3 years of clinical practice.
Plus 2 years in pharmaceutical/biotech/clinical research industry.
OR equivalent education, training, and experience.
License: Valid medical license (preferred).
Skills & Competencies:
Strong understanding of pharmacovigilance regulations and clinical research.
Proven team and project management capabilities.
Excellent communication, stakeholder engagement, and leadership skills.
Strong analytical, decision-making, and problem-solving abilities.
Business acumen and financial awareness.
Experience with safety reporting documentation and regulatory submissions.
About IQVIA:
IQVIA is a global leader in healthcare data, advanced analytics, and clinical research services. We empower healthcare stakeholders to innovate and improve patient outcomes through intelligent, connected solutions.
Learn more and apply at: https://jobs.iqvia.com
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