Cognizant, a global leader in professional services, is seeking an SME-Pharmacovigilance professional to join our dynamic team in Mumbai. This role is critical in ensuring drug safety and compliance with global pharmacovigilance regulations.
Key Responsibilities:
✔ Case Processing & ICSR Management:
- Triage and intake of Individual Case Safety Reports (ICSR) in ARGUS databases.
- Download and monitor ICSRs from EudraVigilance (EV) and other sources.
- Process literature, spontaneous, clinical trial, and solicited cases.
- Perform literature searches for valid ICSRs using specialized tools.
✔ Regulatory Compliance & Reporting:
- Generate and submit safety reports to health authorities and business partners.
- Ensure compliance with GVP, GCP, ICH guidelines, and client SOPs.
- Code adverse events, medical history, and drugs using MedDRA.
✔ Stakeholder Communication & Training:
- Liaise with internal teams and clients on pharmacovigilance matters.
- Attend training sessions to stay updated on regulatory changes.
✔ Operational Excellence:
- Assist in developing and maintaining SOPs for pharmacovigilance processes.
- Support team training and knowledge enhancement in drug safety.
Requirements:
✅ Bachelor’s/Master’s in Pharmacy (B.Pharm/M.Pharm).
✅ 3+ years of experience in pharmacovigilance case processing.
✅ Therapeutic Area Expertise: CVS, CNS, Oncology, Immunology, or Gene Therapy (preferred).
✅ Regulatory Knowledge: GVP, GCP, ICH guidelines, and global pharmacovigilance standards.
✅ Technical Skills: Proficiency in ARGUS, EudraVigilance, MedDRA coding, MS Office.
✅ Soft Skills: Strong communication, time management, and attention to detail.
Why Join Cognizant?
🌍 Global Impact: Work with a Fortune 500 company serving leading pharmaceutical clients.
💡 Innovation-Driven Culture: Be part of a team that values digital transformation and cutting-edge solutions.
🤝 Inclusive Workplace: Cognizant is recognized among Forbes World’s Best Employers 2024.
📈 Career Growth: Opportunities for upskilling and leadership development.
