Job Title: Senior Medical Safety Advisor
Location: Bengaluru, India (with availability in additional locations)
Job ID: R1471135
Job Type: Full-time
Department: Pharmacovigilance / Medical Safety
Company: IQVIA
Job Overview:
The Senior Medical Safety Advisor provides expert medical input into safety data evaluation, ensures scientific relevance of serious adverse event reports, and contributes to the development and review of aggregate safety reports. This position also serves as a technical leader, offering guidance and oversight in post-marketing surveillance and pharmacovigilance activities.
Key Responsibilities:
Medical review and clarification of trial-related AEs and post-marketing ADRs.
Author and review Analyses of Similar Events (AOSE) for expedited cases.
Review coding of AEs, SAEs, SADRs, and other medical data for accuracy.
Act as an internal consultant for case processing and safety teams.
Review safety-related documents such as protocols, IBs, and CRFs.
Conduct aggregate safety data reviews (DSUR, RMP, PBRER, etc.).
Ensure high-quality, compliant service delivery within regulatory timelines.
Provide guidance to other team members and lead safety case assessments.
Maintain and update watch lists, RSIs, labeling lists, and other product-related safety tools.
Contribute to training, audits, knowledge sharing, and product transitions.
Sign off on Project Safety Plans and Medical Monitoring Plans.
Participate in internal and client-facing safety meetings and reviews.
Act as Lead Safety Physician or support physician on assigned projects.
Support signal detection initiatives and provide 24/7 medical coverage as required.
Keep updated with regulatory and industry developments.
Qualifications:
Medical Degree (MD) from an accredited institution (required).
Minimum 3 years of clinical practice experience post-graduation (Residency training acceptable).
At least 2 years of pharmaceutical industry experience (preferred).
Valid medical license or equivalent in the practicing region (preferred).
Strong understanding of Pharmacovigilance, ICSR processing, and aggregate report creation.
In-depth knowledge of ICH-GCP and regulatory guidelines.
Skilled in multiple safety databases and Microsoft Office tools.
Excellent written and verbal communication skills.
Proven ability to collaborate effectively with internal teams and external stakeholders.
About IQVIA:
IQVIA is a global leader in clinical research, healthcare intelligence, and life sciences services. The organization connects data, technology, and expertise to accelerate medical innovations and improve patient outcomes globally.
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