🏷️ Job Title:
Associate Medical Safety Director
Job ID: R1497935
Location: Bengaluru, India (Hybrid)
Employment Type: Full-Time
Job Available in Additional Locations
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🧭 Job Overview
As an Associate Medical Safety Director at IQVIA, you will provide medical expertise to pharmacovigilance services, participating in all aspects of medical safety oversight on assigned clinical trials and stand-alone safety projects. This includes reviewing adverse event data, preparing regulatory safety documents, and providing scientific insight to help ensure the safety and integrity of investigational and marketed products.
🔍 Key Responsibilities
📋 Medical Review & Safety Oversight
Conduct medical review and clarification of:
Clinical trial-related Adverse Events (AEs)
Post-marketing Adverse Drug Reactions (ADRs)
Narrative content, queries, coding, seriousness, causality, and company summaries
Compose, edit, and medically review:
Analyses of Similar Events (AOSE) for expedited case reports
Provide aggregate safety data review for clinical development programs
Review coding for:
AEs, Past Medical History, Concomitant Medications, and other medical data listings
Medically vet safety-related clinical data and findings
📊 Document & Report Review
Provide medical review and input for:
IND Annual Reports
Periodic Safety Update Reports (PSURs)
Development Safety Update Reports (DSURs)
EU Periodic Benefit-Risk Evaluation Reports (PBRERs)
Development Risk Management Plans (RMPs)
US REMS (Risk Evaluation and Mitigation Strategies)
Contribute to:
Integrated Safety Summaries (ISS)
Common Technical Documents (CTDs)
Drug Safety Reports
Benefit-risk assessments
📑 Medical Safety Planning & Monitoring
Review and sign off on:
Project Safety Plans
Medical Monitoring Plans
Conduct safety review of:
Study Protocols
Investigator’s Brochures (IBs)
Case Report Forms (CRFs)
Serve as:
Global Safety Physician, Assistant, or Backup, as assigned
Participate in:
Data Safety Monitoring Board (DSMB) meetings
Safety Monitoring Committee discussions
Project and client meetings related to medical safety
🆘 Escalation & Regulatory Support
Provide medical escalation for:
Medical information and safety projects
EU Qualified Persons for Pharmacovigilance (QPPV) activities
Ensure 24-hour medical support availability on assigned projects
Stay current on industry developments, regulations, and safety science
📚 Qualifications
🎓 Education
Medical Degree from an accredited and internationally recognized medical school
Valid medical license (preferred but not mandatory)
💼 Experience
Minimum 3 years of clinical practice (e.g., residency or graduate medical training)
At least 2 years in the pharmaceutical or associated industry
Equivalent combination of education, training, and experience may be considered
📘 Knowledge & Skills
In-depth understanding of:
Pharmacovigilance regulations (FDA, EMA, ICH, GVP, etc.)
Clinical research process and drug development lifecycle
Strong:
Analytical and prioritization skills
Consultation and problem-solving ability
Interpersonal and stakeholder engagement skills
Flexibility and initiative
Ability to work in a matrix environment and meet tight timelines
🏢 About IQVIA
IQVIA is a global leader in clinical research, healthcare analytics, and real-world evidence. We help life sciences companies accelerate drug development and improve health outcomes through intelligent connections between data, technology, and expertise.
🔗 Learn more at: https://jobs.iqvia.com
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