Senior Medical Safety Advisor – Pharmacovigilance | Bengaluru, India
Work Mode: Home-based
Employment Type: Full-Time
Requisition ID: R1492668
Job Description:
IQVIA is seeking a Senior Medical Safety Advisor to provide expert clinical input in the evaluation of safety data from various sources, including adverse event reports, literature, and post-marketing data. As a senior technical leader, you will contribute to global pharmacovigilance activities such as aggregate reporting, signal detection, and safety surveillance for selected products. The role requires a strong medical background and experience in clinical safety and pharmacovigilance.
Key Responsibilities:
Perform medical review of AEs/SAEs/SADRs including narratives, coding, causality, expectedness, and company comments.
Review and compose Analyses of Similar Events (AOSE) for expedited reports when needed.
Conduct aggregate safety reviews and contribute to periodic reports (DSUR, PBRER, RMP, etc.).
Serve as Lead Safety Physician for designated projects and provide 24-hour medical support when applicable.
Review safety sections of clinical documents like protocols, CRFs, IBs, etc.
Provide guidance to PV teams on case processing and data capture.
Collaborate with clients during project meetings, audits, and regulatory interactions.
Participate in and lead signal detection strategy meetings and safety data analysis efforts.
Oversee and sign off on Project Safety Plans and Medical Monitoring Plans.
Support training, team mentoring, audit readiness, and knowledge transfer initiatives.
Stay updated with medical safety regulations and contribute to internal SOP development.
Required Qualifications:
Medical Degree (MBBS or equivalent) from a recognized institution (mandatory).
Minimum 3 years of clinical practice experience post-MBBS (residency or postgraduate training counts).
Minimum 2 years of industry experience in pharmacovigilance (preferred).
Knowledge of ICH, GCP, global PV regulations, and safety databases.
Experience in aggregate report writing, literature review, and signal detection.
Proficiency in Microsoft Office tools and safety reporting platforms.
Excellent communication, leadership, and cross-functional collaboration skills.
A valid medical license (preferred but not mandatory).
Estimated Salary: ₹32,00,000 – ₹48,00,000 per annum (based on experience and qualifications)
About IQVIA:
IQVIA is a world leader in advanced analytics, clinical research, and technology solutions for the life sciences industry. With a mission to accelerate innovation and improve healthcare outcomes, IQVIA provides a collaborative and empowering work environment.
Apply Now at IQVIA Careers
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