Associate Safety Data Management Specialist
Location: Chennai, India
Job Type: Full-Time
Experience Required: Freshers (B. Pharm, M. Pharm, Pharm.D)
About the Role
This entry-level Pharmacovigilance role focuses on the end-to-end processing of Individual Case Safety Reports (ICSRs) from both clinical trial and post-marketing sources. You will work on the ARGUS Safety database and contribute directly to global drug safety operations by ensuring high-quality case assessment, documentation, and compliance.
Key Responsibilities
Perform case validity assessment and duplicate checks.
Create new cases in the ARGUS Safety database and ensure accuracy of all entered information.
Prioritize and process cases according to organizational guidelines.
Review XML source documents and update relevant case details.
Identify and assess adverse events, seriousness criteria, and causality.
Code products and confirm listedness as per regulatory standards.
Prepare concise and medically accurate narratives for ICSRs.
Determine appropriate follow-up actions for incomplete cases.
Review processed cases to ensure compliance, quality, and technical accuracy.
Maintain adherence to company SOPs and global regulatory requirements.
Minimum Qualifications
Education: B. Pharm, M. Pharm, or Pharm.D (Mandatory).
Experience: Freshers only.
Strong analytical capabilities and attention to detail.
Excellent written and verbal communication skills.
Ability to collaborate within cross-functional teams.
Willingness to learn continuously in a dynamic pharmacovigilance environment.
Preferred Qualifications
Certification or formal training in Pharmacovigilance.
Knowledge of medical terminology and global drug safety regulations.
Published research or articles in peer-reviewed journals.
Work Mode
Hybrid work model.
About the Employer
Pfizer is committed to equal employment opportunities and adheres to all applicable global and regional regulations. The organization fosters an inclusive workplace that values diverse perspectives and continuous professional growth.
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