Clinical Project Assistant
SanofiÂ
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Job Description
 Location: Chennai, India (Hybrid)
Job ID: 4943867
Job Overview
Pfizer is one of the world’s premier biopharmaceutical companies, dedicated to discovering, developing, and delivering innovative medicines that improve health and save lives. In this pharmacovigilance role, you will be responsible for performing key safety data management activities within the ARGUS Safety database. This position focuses on ensuring the accurate processing and assessment of Individual Case Safety Reports (ICSRs) from both clinical trials and post-marketing sources, in compliance with global regulatory and company standards.
Role & Responsibilities
- Perform end-to-end processing of Individual Case Safety Reports (ICSRs) from clinical and post-marketing sources.
- Assess case validity and perform duplicate checks to ensure data accuracy.
- Create and update cases in the ARGUS Safety database using XML source documents.
- Identify and evaluate adverse events, determine seriousness, and perform causality and listedness assessments.
- Code products, draft case narratives, and determine appropriate case follow-up actions.
- Review processed cases to verify technical accuracy, judgment, and compliance with Pfizer’s quality standards.
- Prioritize cases according to company guidelines to ensure timely and accurate reporting.
- Collaborate with cross-functional teams to maintain regulatory compliance and operational efficiency.
Educational Qualification
- B. Pharm, M. Pharm, or Pharm. D (required).
- Fresh graduates only (no prior experience required).
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication abilities.
- High attention to detail and commitment to data accuracy.
- Ability to work collaboratively in a team environment.
- Commitment to continuous learning and professional development.
Location
Chennai, India (Hybrid)
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