Associate Safety Data Management Specialist – Chennai
Location: Chennai, India
Work Mode: Hybrid (Full-time)
Salary/Compensation: Not specified in the job description
Job Summary
Pfizer is hiring an Associate Safety Data Management Specialist to manage Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing sources. The role involves working with the ARGUS safety database, performing causality and seriousness assessments, coding, and ensuring compliance with global pharmacovigilance regulations. This is a key role for professionals aiming to build expertise in drug safety and case processing.
Key Responsibilities
Process ICSRs, including validity checks, duplicate detection, case creation, and prioritization.
Code adverse events, assess seriousness, causality, and listedness.
Draft case narratives and determine appropriate follow-up actions.
Review processed cases to ensure accuracy and compliance with company and regulatory standards.
Handle XML source documents (E2B R2 and R3) and update the ARGUS safety database.
Collaborate with cross-functional teams to ensure timely case submissions.
Maintain thorough knowledge of global regulatory requirements and pharmacovigilance practices.
Required Skills & Qualifications
B. Pharm, M. Pharm, or Pharm. D (mandatory).
1–2 years of experience in end-to-end ICSR processing.
Knowledge of medical terminology and global drug safety regulations.
Strong analytical, communication, and documentation skills.
Attention to detail and ability to work collaboratively in a fast-paced environment.
Continuous learning mindset and adaptability.
Preferred Qualifications
Hands-on experience with the ARGUS safety database.
Proficiency in XML source document processing (E2B R2/R3).
Certification in pharmacovigilance or related publications.
Perks & Benefits
Work with a global leader in pharmaceutical innovation.
Hybrid work model with career growth opportunities.
Exposure to advanced pharmacovigilance tools and international projects.
Competitive benefits package (as per company policy).
Company Description
Pfizer is one of the world’s premier biopharmaceutical companies, known for driving healthcare innovation. With a strong focus on patient safety, Pfizer’s pharmacovigilance team ensures high-quality data analysis and compliance with regulatory requirements across global markets.
Work Mode: Hybrid (Chennai, India)
Call-to-Action
Are you passionate about drug safety and pharmacovigilance? Apply now for the Associate Safety Data Management Specialist role at Pfizer and advance your career with a global healthcare leader.
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