Associate Medical Safety Director – Bengaluru, India
Full-Time | Hybrid | Job ID: R1497935
Global Openings Available
About the Role
The Associate Medical Safety Director provides expert medical oversight for pharmacovigilance activities across clinical trials and post-marketing safety programs. This role involves comprehensive medical review of safety data, regulatory documentation, risk management activities, and cross-functional safety support. You will work closely with clinical, regulatory and safety operations teams to ensure compliance, accuracy, and timely delivery of all safety-related outputs.
This position is ideal for experienced medical professionals seeking a global role in drug safety and clinical research.
Key Responsibilities
Conduct medical review and clarification of trial-related Adverse Events (AEs) and post-marketing Adverse Drug Reactions (ADRs), including assessment of narratives, coding, causality, seriousness, and expectedness.
Prepare, edit, and medically review Analyses of Similar Events (AOSE) for expedited regulatory cases.
Serve as a subject matter expert to pharmacovigilance case-processing teams.
Perform aggregate safety evaluations of clinical and post-marketing data to ensure continuous monitoring of product safety profiles.
Review medical coding of AEs, medical history, concomitant medications, and other clinical data for accuracy.
Represent medical safety insights in client meetings and cross-functional reviews.
Provide medical review and edits to regulatory submissions including:
IND Annual Reports
Periodic Benefit-Risk Evaluation Reports (PBRER)
Periodic Safety Update Reports (PSUR)
Development Safety Update Reports (DSUR)
US Periodic Reports
Contribute to Development Risk Management Plans, EU Risk Management Plans, and REMS documents.
Provide medical oversight for product labeling, safety-related changes, and updates.
Support Data Safety Monitoring Boards (DSMB) and Safety Monitoring Committees (SMC).
Provide medical input to Integrated Safety Summaries and Common Technical Document (CTD) sections.
Review Project Safety Plans, Medical Monitoring Plans, protocols, Investigator Brochures (IB), and Case Report Forms (CRFs).
Serve as Global Safety Physician, Assistant, or Back-Up based on project requirements.
Participate in internal and client-facing safety meetings.
Ensure timely delivery of all medical safety outputs within regulatory and contractual timelines.
Provide medical escalation support for Medical Information and QPPV teams.
Deliver 24-hour on-call medical safety support for assigned projects.
Maintain current knowledge of global safety regulations and industry best practices.
Required Qualifications & Experience
Medical Degree (MBBS or equivalent) from an accredited and internationally recognized institution.
Minimum 3 years of clinical practice experience (postgraduate training or equivalent).
Minimum 2 years of experience in the pharmaceutical industry or related drug safety/clinical research roles, or an equivalent combination of education and experience.
Strong understanding of global pharmacovigilance regulations, ICH guidelines, and Good Clinical Practice (GCP).
In-depth knowledge of clinical trial processes and safety management workflows.
Demonstrated ability to manage multiple priorities and meet strict deadlines.
Strong analytical, consultative, and communication skills.
Proven ability to collaborate with cross-functional global teams.
Valid medical license from the country or region of practice (preferred).
About IQVIA
IQVIA is a global leader in clinical research, data science, and healthcare intelligence. With advanced analytics and operational expertise, IQVIA accelerates the development and commercialization of innovative therapies that improve patient outcomes worldwide.
Learn more at IQVIA Careers.
How to Apply
Click Apply Now to submit your application through our global recruitment platform.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Delhi | India | New Delhi | PAN-India |Assam :
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Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Frank Scottile Blvd |Missouri :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
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