Associate Medical Safety Director
📍 Location: Bengaluru, India (Home-based / Hybrid Option)
🕓 Job Type: Full-time
🆔 Requisition ID: R1500619
🏢 Company: IQVIA
Job Overview
The Associate Medical Safety Director provides medical expertise in pharmacovigilance services, supporting assigned clinical trials and standalone safety projects.
You will ensure medical oversight, data accuracy, and compliance with global safety regulations under the guidance of senior medical safety leadership.
Key Responsibilities
Medical Review & Case Evaluation
Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing Adverse Drug Reactions (ADRs).
Assess and verify narrative content, seriousness, causality, coding, and expectedness.
Author and review Analyses of Similar Events (AOSE) for expedited cases as per regulatory requirements.
Safety Oversight & Data Analysis
Conduct aggregate reviews of safety data to monitor and evaluate the product safety profile.
Provide medical coding review for AEs, medical histories, concomitant medications, and related clinical data.
Participate in Safety Monitoring Committees (SMCs) and Data Safety Monitoring Board (DSMB) meetings.
Maintain oversight on labeling, including label review and change control processes.
Regulatory & Document Support
Provide medical review and edits for:
IND Annual Reports
Periodic Benefit-Risk Evaluation Reports (PBRERs)
Periodic Safety Update Reports (PSURs)
Development Safety Update Reports (DSURs)
Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS)
Contribute to Integrated Safety Summaries and Common Technical Documents (CTDs).
Review and sign off on the Project Safety Plan and Medical Monitoring Plan.
Conduct medical safety reviews of protocols, Investigator’s Brochures (IBs), and Case Report Forms (CRFs).
Cross-Functional Collaboration
Act as Global Safety Physician, Assistant, or Backup as assigned.
Provide consultation to pharmacovigilance case processing teams and medical information projects.
Represent safety and clinical data findings during client and internal meetings.
Ensure medical coverage for all safety deliverables within contractual and regulatory timelines.
Leadership & Support
Offer medical escalation support for EU QPPV and medical information projects.
Provide 24-hour on-call support for assigned projects.
Stay updated on regulatory, medical, and pharmacovigilance developments.
Qualifications
Required
Medical Degree (MD/MBBS) from an accredited and internationally recognized medical school.
Minimum 3 years of clinical practice experience plus 2 years in the pharmaceutical or allied industry, or equivalent combination of education and experience.
Strong understanding of pharmacovigilance, clinical research regulations, and Good Clinical Practice (GCP).
Demonstrated ability to manage multiple projects, meet deadlines, and adapt in a dynamic environment.
Excellent consulting, analytical, and communication skills.
Proven ability to build and maintain effective working relationships with cross-functional teams and clients.
Preferred
Valid medical license (local or international).
Prior experience in global pharmacovigilance or drug safety leadership roles.
About IQVIA
IQVIA is a global leader in clinical research, healthcare data analytics, and life sciences innovation.
We deliver intelligent connections between science and data to accelerate the development of innovative medical treatments that improve patient outcomes and advance global health.
🌐 Learn more: https://jobs.iqvia.com
Summary
As an Associate Medical Safety Director at IQVIA, you’ll play a critical role in ensuring the medical and scientific integrity of safety data across clinical and post-marketing programs. This position demands strong clinical acumen, regulatory understanding, and collaboration skills to uphold IQVIA’s commitment to global patient safety.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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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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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Big Piney | Cokeville |Alabama :
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Boulder | Denver | Westminster |Connecticut :
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Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
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Frank Scottile Blvd |Missouri :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Sheffield |Oxfordshire :
Witney |Ontario :
Uxbridge | North York | Mississauga | Renfrew | Richmond Hill | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Athens | Koropi |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 :
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Japan | Saitama |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
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Bangkok |Israel :
Kfar Saba | Yavne | Be'Er Sheva | Tel Aviv | Netanya |Remote :
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Paris | Lyon |South Africa :
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Prague |Chile :
Santiago |Bosnia and Herzegovina :
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