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Job Title: Specialist/Team Lead – Pharmacovigilance
Company: Cognizant
Location: Global (Hybrid Work Model)
About Us:
Join a leading global technology services provider, an AI Builder dedicated to developing innovative solutions that advance healthcare and drive tangible outcomes worldwide. We are committed to fostering an environment where human potential is amplified through cutting-edge technology and services.
Job Summary:
We are seeking a dedicated Specialist/Team Lead in Pharmacovigilance to contribute significantly to global medicine safety. In this hybrid day shift role, you will apply foundational experience in safety data handling and clinical documentation to ensure compliant case management and timely reporting. Your expertise will support high-quality pharmaceutical research and development activities, ultimately strengthening public trust in healthcare innovations.
Key Responsibilities:
- Perform end-to-end pharmacovigilance case handling: ensuring accurate data capture, clear narratives, and consistent application of internal procedures.
- Review source documents and clinical R&D data, validating medical information to identify critical safety details for robust product risk/benefit evaluation.
- Execute standardized workflows for adverse event intake, classification, and data entry, maintaining high data quality and compliance with global pharmacovigilance regulations.
- Conduct detailed medical assessments of individual case safety reports (ICSRs), confirming seriousness and expectedness, and escalating complex or medically sensitive cases as needed.
- Prepare regulatory-compliant ICSR outputs (including narratives and structured data) for timely electronic submission to health authorities.
- Coordinate with cross-functional teams in clinical operations and quality to resolve data inconsistencies and ensure safety records align with current documentation.
- Adhere strictly to internal standard operating procedures (SOPs) and global pharmacovigilance guidelines, supporting audit-ready safety systems and continuous process improvement.
Qualifications:
- Practical experience in pharmaceutical research and development, with at least one year of exposure to clinical or safety-related documentation.
- Familiarity with pharmacovigilance case processing concepts: data capture, seriousness assessment, and narrative preparation.
- Foundational understanding of individual case safety report (ICSR) submission practices and regulatory compliance.
- Strong attention to detail in reviewing medical data and adverse event descriptions.
- Effective written and verbal communication skills for collaboration in a hybrid work environment.
- Preferred: Certifications in pharmacovigilance or drug safety from recognized industry bodies.
Why Join Us?
Make a tangible impact on global medicine safety and patient outcomes within a dynamic and supportive environment. Contribute directly to advancing healthcare innovation.
Apply Now:
Ready to leverage your skills in this crucial role? We invite you to apply today!
Equal Opportunity Employer:
We are an equal opportunity employer, committed to diversity and inclusion. All qualified applicants receive consideration without regard to protected characteristics. Reasonable accommodations are provided for applicants with disabilities.
