Cognizant, a global leader in technology and healthcare solutions, is actively hiring for the role of Subject Matter Expert (SME) – Pharmacovigilance at its Mumbai location. This is an exciting opportunity for skilled professionals to join a high-impact team dedicated to ensuring drug safety and regulatory compliance on a global scale.
🔬 About the Role
The SME – Pharmacovigilance plays a critical role in enhancing drug safety operations. This position demands expertise in Individual Case Safety Report (ICSR) processing, effective communication with stakeholders, and adherence to global regulatory standards. The ideal candidate will have strong experience in ARGUS database handling and an in-depth understanding of Good Pharmacovigilance Practices (GVP), ICH guidelines, and therapeutic areas such as oncology, CNS, immunology, and more.
📝 Key Responsibilities
- Case Processing: Triage, intake, and process ICSRs (spontaneous, literature, clinical trial, and solicited) using ARGUS within defined timelines.
- Regulatory Submissions: Generate and submit reports to health authorities and global business partners.
- Medical Coding: Code events, products, and indications using MedDRA; ensure narrative accuracy and label events appropriately.
- Literature Monitoring: Perform regular literature searches and identify reportable safety information.
- Compliance & Documentation: Ensure compliance with SOPs, regulatory guidelines (GVP, GCP, ICH), and internal quality standards.
- Client Interaction: Communicate effectively with client stakeholders and support regulatory audits.
- Process Improvement: Contribute to SOP development, resolve technical/process-related issues, and support internal training.
- Flexible Support: Work in rotational shifts to ensure 24/7 global PV support.
✅ Candidate Requirements
- Education: Bachelor’s or Master’s degree in Pharmacy
- Experience: Minimum 3 years of relevant work experience in pharmacovigilance case processing
- Preferred Background: Experience in therapeutic areas like Cardiovascular, CNS, Oncology, Immunology, and Gene Therapy
- Skills:
- Hands-on experience with ARGUS Safety Database
- Strong knowledge of global regulatory guidelines (GVP, ICH, GCP)
- Excellent written and verbal communication skills
- Good understanding of medical terminology
- Proficiency in Microsoft Office (Word, Excel, PowerPoint)
🌟 Why Join Cognizant?
Cognizant offers a robust platform for career growth, innovation, and cross-functional collaboration in the life sciences domain. The hybrid work model, global exposure, and cutting-edge technology make it an ideal environment for pharmacovigilance professionals aiming to make an impact in patient safety and public health.
📍 Location: Mumbai, India
💼 Employment Type: Full-time
🔁 Work Model: Hybrid
🆔 Job Number: 00064279272
📬 How to Apply
To apply, visit www.cognizant.com/careers and search for Job ID: 00064279272.
Take the next step in your pharmacovigilance career with Cognizant — where your expertise contributes to global healthcare safety.
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