Sr Medical Safety Advisor – Bengaluru (Hybrid)
Salary/Compensation: Not specified in the job description.
Job Summary
IQVIA is seeking a Sr Medical Safety Advisor with expertise in pharmacovigilance, medical review, and aggregate safety reporting. The role involves evaluating safety data from clinical trials and post-marketing surveillance, ensuring compliance with ICH, GCP, and global pharmacovigilance standards, and providing leadership in safety signal management and regulatory submissions.
Key Responsibilities
Perform medical review and assessment of adverse events (AEs) and serious adverse events (SAEs) from clinical and post-marketing data.
Review and medically validate coding, narratives, causality, expectedness, and seriousness for adverse events.
Author and review Analyses of Similar Events (AOSE) and regulatory safety reports (DSUR, RMP, PBRER, etc.).
Provide therapeutic area expertise and consult on pharmacovigilance projects.
Ensure compliance with regulatory timelines for case processing and safety submissions.
Lead training sessions, audit preparations, and product safety knowledge transitions.
Participate in signal detection and safety surveillance strategies.
Collaborate with cross-functional safety and clinical teams for data review and regulatory responses.
Provide medical escalation support and 24-hour medical coverage on assigned projects.
Required Skills & Qualifications
Medical degree (MD or equivalent) from an accredited institution.
Minimum 3 years of clinical practice experience post-graduation (Residency or Graduate training counts).
2+ years of pharmaceutical or pharmacovigilance experience preferred.
Strong knowledge of GCP, ICH guidelines, and global PV regulations.
Expertise in ICSR, aggregate reports, and safety databases.
Proficiency in MS Office (Word, Excel, PowerPoint).
Excellent written and verbal communication skills.
Valid medical license (preferred).
Perks & Benefits
Lead global pharmacovigilance initiatives and safety evaluations.
Work in a hybrid environment with flexible schedules.
Opportunity for career growth in drug safety and regulatory compliance.
Exposure to complex safety signal and aggregate report projects.
Company Description
IQVIA is a global leader in clinical research, healthcare analytics, and pharmacovigilance services, enabling life sciences companies to bring innovative therapies to market faster. Through advanced safety and regulatory intelligence, IQVIA supports better patient outcomes worldwide.
Work Mode: Hybrid – Bengaluru, India
Call-to-Action
Step into a key leadership role in pharmacovigilance and drug safety. Apply now to join IQVIA as a Sr Medical Safety Advisor and advance your career in global safety surveillance.
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