Associate Medical Safety Director
Kochi, India
Job available in additional locations
Full-time
R1474799
The Associate Medical Safety Director provides expert medical oversight in pharmacovigilance and safety services across clinical trials and standalone safety projects. This role involves comprehensive medical review of safety data, regulatory reporting, and close collaboration with cross-functional teams. The position works under the guidance of senior medical safety leadership.
Conduct medical review and clarification of trial-related Adverse Events (AEs) and Adverse Drug Reactions (ADRs):
Evaluate narrative content, seriousness, expectedness, causality, coding, and company summaries.
Review and medically edit Analyses of Similar Events (AOSE) for expedited cases.
Provide aggregate reviews of clinical and safety data to monitor overall product safety profiles.
Perform coding review for AEs, medical history, concomitant medications, and other listings.
Provide medical review and input into:
IND Annual Reports
EU PSURs, PBRERs, DSURs
US Periodic Safety Reports
Risk Management Plans (EU and US)
Integrated Safety Summaries (ISS)
Common Technical Documents (CTDs)
Development Risk Management Plans
Drug Safety Reports and benefit-risk assessments
Represent medical safety during client and internal meetings.
Attend and contribute to Data Safety Monitoring Board (DSMB) and Safety Monitoring Committee (SMC) meetings.
Provide 24-hour medical support coverage for assigned projects, as needed.
Ensure timely delivery and medical sign-off for all safety-related project documents.
Act as Global Safety Physician, Assistant, or Back-up as assigned.
Review and sign off on:
Project Safety Plans
Medical Monitoring Plans
Study Protocols
Investigator Drug Brochures (IDBs)
Case Report Forms (CRFs) for safety data alignment
Provide medical escalation support for:
Medical Information projects
EU Qualified Person for Pharmacovigilance (QPPV) projects
Stay updated on industry regulations and medical safety standards.
Ensure medical safety compliance with regulatory and contractual timelines.
| Requirement | Details |
|---|---|
| Education | Medical degree from an accredited, internationally recognized institution (Required) |
| Experience | Minimum 3 years of clinical practice + 2 years in the pharmaceutical or related industry (or equivalent experience) |
| Licensing | Valid medical license (Preferred but not mandatory) |
| Knowledge | In-depth understanding of safety regulations, Good Clinical Practice (GCP), and clinical research processes |
| Skills | Strong consultation, prioritization, and decision-making abilities; able to manage multiple tasks and maintain strong relationships with internal and external stakeholders |
IQVIA is a global leader in healthcare analytics, clinical research, and technology-enabled services. By connecting data, science, and innovation, IQVIA supports the development and commercialization of life-changing medical treatments that improve patient outcomes worldwide.
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