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Associate Safety Data Management Specialist

1-2 years
Not Disclosed
10 July 28, 2025
Job Description
Job Type: Hybrid Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.