Position: Senior Medical Safety Advisor
📍 Location: Bengaluru, India (Hybrid)
📍 Additional Location: Ahmedabad, India
🏢 Company: IQVIA
🕒 Employment Type: Full-Time
💼 Job ID: R1497941
About IQVIA
IQVIA is a global leader in clinical research services, commercial insights, and healthcare intelligence for the life sciences industry.
We create intelligent connections to accelerate the development and commercialization of innovative medical treatments — improving patient outcomes and population health worldwide.
🔗 Learn more: https://jobs.iqvia.com
Job Overview
The Senior Medical Safety Advisor (SMSA) provides medical expertise in pharmacovigilance, evaluating safety data from multiple sources and determining the medical and scientific relevance of adverse events.
This role also functions as a senior technical leader, participating in matrix management, evaluating safety issues, preparing aggregate reports, and overseeing surveillance activities for selected products.
Key Responsibilities
Medical Review & Oversight
Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing Adverse Drug Reactions (ADRs), including narrative content, queries, coding, expectedness, seriousness, causality, and company summaries.
Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases based on regulatory requirements.
Provide coding review of AEs, SAEs, SADRs, past medical history, concomitant medications, and other clinical data.
Conduct medical safety review of protocols, Investigative Brochures, and Case Report Forms (CRFs) for safety content and data capture.
Provide aggregate reviews of safety information, including clinical data, post-marketing data, literature, and observational studies.
Project & Stakeholder Management
Serve as internal consultant to pharmacovigilance case processing teams.
Lead and participate in training, product transitions, audit preparation, and knowledge exchange initiatives.
Review and sign off on Project Safety Plan and Medical Monitoring Plan per medical safety scope.
Represent safety and clinical data findings during client meetings.
Act as Lead Safety Physician or backup for assigned projects.
Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects.
Provide 24-hour medical support as required on assigned projects.
Compliance & Continuous Learning
Maintain awareness of medical safety regulatory industry developments.
Ensure compliance with departmental SOPs, global/regional regulations, and company policies.
Qualifications & Requirements
Education & Licensure
Medical degree from an accredited and internationally recognized medical school.
Valid medical license (or equivalent) in the country/region of practice preferred.
Experience
3 years of clinical practice post-medical degree (graduate or residency training qualifies).
2 years of pharmaceutical experience preferred.
Knowledge & Skills
Sound knowledge of Medicine and pharmacovigilance processes.
In-depth knowledge of global, regional, and local clinical research regulatory requirements (GCP, ICH guidelines).
Understanding of ICSR and aggregate report preparation.
Proficiency with safety databases and Microsoft Office applications (Word, Excel, PowerPoint).
Strong communication, analytical, and interpersonal skills.
Ability to maintain effective working relationships with coworkers, managers, clients, and regulatory agencies.
Why Join IQVIA?
🌍 Work with a global leader in clinical research and healthcare intelligence.
💡 Contribute to pharmacovigilance and patient safety on a global scale.
🤝 Collaborate in a hybrid, flexible, and supportive work environment.
🌐 Opportunities to advance your career and expertise in medical safety.
📩 Apply Now: IQVIA Careers – Senior Medical Safety Advisor
Gujarat :
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Tallinn |Hà Nội :
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Kyiv |Lima Region :
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