Job Title: Senior Medical Safety Advisor
Location: Bengaluru, India
Job ID: R1471135
Job Type: Full-time
Job Available in Additional Locations
Job Overview:
As a Senior Medical Safety Advisor, you will provide in-depth medical expertise for evaluating safety data across clinical and post-marketing settings. You will assess the medical relevance of serious adverse events within a product’s safety profile and therapeutic area. This role involves taking the lead in safety surveillance, aggregate report preparation, and cross-functional leadership in pharmacovigilance projects.
Essential Functions:
Conduct medical review and clarification of trial-related AEs and post-marketing ADRs, including narrative content, coding, seriousness, causality, and company summary.
Compose, edit, and medically review Analyses of Similar Events (AOSE) as per regulatory requirements.
Provide expert coding review for AEs, SAEs, SADRs, medical history, and concomitant medications to ensure data quality.
Act as a consultant for PV case processing teams on ongoing projects.
Perform protocol and Case Report Form (CRF) safety content reviews.
Aggregate safety data review from clinical data, literature, and observational studies for DSURs, RMPs, PBRERs, and other regulatory reports.
Ensure quality service delivery within regulatory timelines; lead related initiatives to enhance compliance and productivity.
Guide pharmacovigilance team members on safety issues and therapeutic area expertise.
Update and manage watch lists, RSI documents, labeling expectations, etc., for assigned products.
Lead and contribute to product transitions, training, audits, and knowledge transfer.
Review and sign off Project Safety Plans and Medical Monitoring Plans.
Represent clinical and safety data findings in internal and client-facing meetings.
Serve as Lead Safety Physician or supporting team member on projects.
Provide 24-hour medical support for designated projects.
Support medical escalations and collaborate with EU QPPV as needed.
Stay current with evolving safety and regulatory industry standards.
Contribute to signal detection strategies and related meetings.
Qualifications:
Education: Medical degree from an accredited and internationally recognized medical school.
Experience:
Minimum 3 years clinical medical practice experience (post-medical degree).
At least 2 years of experience in the pharmaceutical industry (preferred).
Skills & Competencies:
Deep knowledge of medicine and pharmacovigilance processes (ICSR, aggregate reports).
Understanding of global GCP, ICH, and regulatory standards.
Familiarity with safety databases and Microsoft Office tools.
Effective verbal and written communication skills.
Ability to collaborate across functions, manage stakeholders, and contribute to regulatory-facing discussions.
Valid medical license (preferred).
About IQVIA:
IQVIA is a global leader in healthcare data science, providing advanced analytics, clinical research services, and real-world evidence to accelerate medical innovations and improve health outcomes globally.
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