Job Title: Associate Safety Data Management Specialist
Location: Chennai, India (Hybrid)
Employment Type: Full-Time
Job Requisition ID: 4945341
Posted: Yesterday
Role Summary:
As an Associate Safety Data Management Specialist in Pharmacovigilance, you will be responsible for processing Individual Case Safety Reports (ICSRs) from both clinical trials and post-marketing sources in the ARGUS Safety database. This role focuses on ensuring accurate, timely, and compliant reporting of adverse events.
Key Responsibilities:
Assess case validity and perform duplicate checks.
Create and update cases in the ARGUS Safety database using information from XML source documents.
Prioritize cases according to company guidance.
Identify adverse events, confirm their seriousness, and code products.
Conduct causality and listedness assessments.
Draft case narratives and determine appropriate follow-up actions.
Review processed cases to ensure accuracy, technical judgment, and compliance with company standards.
Minimum Requirements:
Education: B.Pharm, M.Pharm, or Pharm.D.
Experience: Freshers only.
Strong attention to detail and analytical skills.
Good written and oral communication skills.
Ability to work collaboratively and willingness for continuous learning.
Preferred Qualifications / Bonus Points:
Certification or course completion in Pharmacovigilance.
Knowledge of medical terminology and global regulatory requirements for drug safety.
Publications in peer-reviewed journals.
Work Location: Hybrid (Chennai, India)
Equal Opportunity Employer Statement:
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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