Senior Medical Safety Advisor – Pharmacovigilance
Location: Bengaluru, India
Work Mode: Hybrid
Employment Type: Full-Time
Requisition ID: R1492686
Job Overview:
IQVIA is hiring a Senior Medical Safety Advisor to provide expert-level medical review and oversight for adverse event and drug reaction data. This role is essential in ensuring medical accuracy, safety compliance, and regulatory preparedness across pharmacovigilance operations. You will also take on a leadership role within matrix teams, focusing on safety data evaluation, aggregate reporting, signal detection, and regulatory documentation for assigned products.
Key Responsibilities:
Perform medical review of AEs and ADRs, including narratives, seriousness, causality, and expectedness.
Compose and review Analyses of Similar Events (AOSE) in line with regulatory requirements.
Evaluate coding and clinical data: AEs, SAEs, past medical history, concomitant medications, etc.
Conduct medical safety reviews of trial protocols, case report forms (CRFs), and investigator brochures.
Lead or support aggregate safety reporting efforts (DSURs, PBRERs, RMPs, ad hoc reports).
Participate in signal detection, literature surveillance, and product safety surveillance activities.
Review and approve Project Safety Plans and Medical Monitoring Plans.
Act as Lead Safety Physician or provide backup support for assigned projects.
Guide pharmacovigilance team members and contribute to training, audits, and project transitions.
Support regulatory interactions and escalate medical issues as needed.
Ensure compliance with GCP, ICH, global PV regulations, and company SOPs.
Maintain awareness of evolving global pharmacovigilance standards and participate in knowledge-sharing initiatives.
Qualifications:
Medical Degree (MBBS or equivalent) from a recognized institution (mandatory).
Minimum 3 years of clinical medical practice post-graduation (residency or PG counts).
Minimum 2 years of pharmaceutical industry experience in pharmacovigilance (preferred).
Strong knowledge of medicine, drug safety regulations, ICSR, and aggregate reporting.
Familiarity with safety databases and pharmacovigilance documentation.
Proficiency in Microsoft Word, Excel, PowerPoint.
Excellent written and verbal communication, time management, and analytical skills.
A valid medical license is preferred.
Estimated Salary: ₹30,00,000 – ₹46,00,000 per annum (based on experience and location)
About IQVIA:
IQVIA is a global leader in clinical research, healthcare analytics, and technology-enabled solutions. Join us to help transform patient outcomes and shape the future of medical innovation.
Apply Now at IQVIA Careers
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