Associate Safety Data Management Specialist
Location: Chennai, India
Employment Type: Full Time
Experience Required: Fresher
Job ID: 4946396
About the Role
This entry-level position offers an opportunity to begin a career in pharmacovigilance with hands-on responsibility for processing Individual Case Safety Reports (ICSRs) across clinical trial and post-marketing sources. The selected candidate will work within the ARGUS Safety database, ensuring high-quality and compliant case management.
Key Responsibilities
Review and assess ICSR validity for clinical and post-marketing sources.
Perform duplicate checks and create new safety cases in the ARGUS system.
Prioritize cases in alignment with organizational guidelines.
Update case files based on details received through XML source documents.
Identify adverse events, evaluate seriousness, and perform MedDRA product coding.
Conduct causality, listedness, and clinical relevance assessments.
Draft clear and accurate patient safety narratives.
Determine appropriate case follow-up requirements.
Complete end-to-end case processing while maintaining data accuracy and compliance with internal and regulatory standards.
Minimum Requirements
Education: B. Pharm, M. Pharm, or Pharm. D (mandatory).
Experience: Freshers only.
Strong attention to detail and analytical mindset.
Effective written and verbal communication skills.
Ability to collaborate within cross-functional teams.
Commitment to continuous learning and quality-driven work.
Preferred Qualifications
Certification or formal training in Pharmacovigilance.
Understanding of medical terminology and global drug safety regulations.
Publications in peer-reviewed journals.
Work Mode
Hybrid work arrangement.
Equal Opportunity Statement
The organization follows all applicable equal employment opportunity laws across all operating regions.
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