Associate Safety Data Management Specialist – Pfizer, Chennai
Job Summary:
Pfizer is seeking a detail-oriented Associate Safety Data Management Specialist for its Pharmacovigilance team in Chennai. This role involves comprehensive ICSR case processing for both clinical trials and post-marketing sources, working with the ARGUS safety database. Ideal for candidates with 1–2 years of PV experience and a strong grasp of global regulatory standards and safety databases.
Key Responsibilities:
Process Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing sources
Assess case validity and perform duplicate checks
Input case data into the ARGUS Safety database and update with XML source information
Identify and code adverse events and medical products
Conduct seriousness, causality, and listedness assessments
Draft case narratives and determine necessary follow-up actions
Ensure compliance with regulatory and internal guidelines
Review processed cases for accuracy and technical consistency
Required Skills & Qualifications:
Education: B. Pharm, M. Pharm, or Pharm.D
1–2 years of hands-on experience in pharmacovigilance and end-to-end ICSR processing
Familiarity with global PV regulations and medical terminology
Strong analytical abilities and attention to detail
Effective written and oral communication skills
Ability to work collaboratively in a team environment
Continuous learning mindset
Preferred Qualifications:
Experience with the ARGUS safety database
Proficiency with E2B R2/R3 XML source documents
Pharmacovigilance certification or training
Peer-reviewed publications in relevant areas
Perks & Benefits:
Competitive salary and compensation
Hybrid work environment
Access to Pfizer’s comprehensive employee benefit programs
Opportunities for professional learning and development
Inclusive, global work culture
Company Description:
Pfizer is a global leader in innovative biopharmaceuticals, dedicated to breakthroughs that transform patients’ lives. With cutting-edge research, robust clinical programs, and a commitment to quality, Pfizer remains at the forefront of drug discovery and development worldwide.
Work Mode: Hybrid (Chennai, India)
Call-to-Action:
If you're passionate about drug safety and ready to build your career with a global leader, apply now to join Pfizer’s Pharmacovigilance team in Chennai.
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