Senior Drug Safety Physician
Location: Karnataka, India
Posted On: 17 November 2025
Category: Drug Safety / Pharmacovigilance
Overview
This position is with a leading technology-driven healthcare solutions organization committed to enabling global healthcare companies to become future-ready. The role offers accelerated career growth within a high-performance environment, where innovation, scientific excellence, and operational agility guide everyday work.
As a Senior Drug Safety Physician, you will work at the intersection of clinical science, pharmacovigilance, and healthcare technology. You will collaborate with multidisciplinary teams and contribute to high-quality medical review processes that support global safety compliance.
Key Responsibilities
Conduct comprehensive medical evaluation of adverse event reports, including all serious, expedited, and pregnancy-related cases.
Provide scientific and medical guidance to drug safety associates, physicians, and cross-functional safety teams to ensure high-quality follow-up and evaluation of Individual Case Safety Reports (ICSRs).
Perform detailed medical review of ICSRs for accuracy, clinical relevance, consistency, and compliance with client requirements and regulatory expectations.
Assess causality for all drugs, including vaccines, and evaluate seriousness, listedness, and correctness of medical coding for reported adverse events.
Ensure all medically relevant information is accurately captured from source documents and provide final medical sign-off.
Review and document Quality Check (QC) observations in alignment with established checklists and internal quality standards.
Review literature articles to determine case validity and seriousness criteria as part of routine pharmacovigilance surveillance.
Adhere to international pharmacovigilance regulations, company SOPs, and departmental work practices.
Required Qualifications & Experience
MBBS or equivalent medical degree is mandatory.
Minimum 2 years of experience performing medical review of ICSRs within drug safety or pharmacovigilance operations.
Strong knowledge of AE coding, listedness assessment, causality assessment, and evaluation of literature articles for case validity.
Proficiency with safety databases, preferably ARGUS.
Preferred Skills
Experience in global pharmacovigilance processes and international regulatory requirements.
Detail-oriented approach with strong analytical and clinical interpretation skills.
Ability to collaborate effectively with cross-functional medical and scientific teams.
Impact of the Role
In this position, you will directly contribute to the accuracy, reliability, and regulatory compliance of safety data that supports patient protection and global drug safety operations. Your expertise will help maintain the integrity of safety information across healthcare products and therapies worldwide.
Equal Opportunity Commitment
The employer is an Equal Opportunity Organization committed to fostering an inclusive and diverse work environment. All employment decisions are based solely on business needs, role requirements, and individual qualifications. Applicants will receive equal consideration without regard to race, color, religion, sex, national origin, gender identity, sexual orientation, disability, veteran status, or any other protected characteristic.
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