Cognizant has published an opening for SPE – Pharmacovigilance in India. The role focuses on pharmacovigilance case processing, adverse event documentation, individual case safety report (ICSR) preparation, and regulatory compliance. Candidates with experience in pharmaceutical research and development, clinical documentation, or drug safety activities can explore this opportunity.
Job Details
| Particulars | Details |
|---|---|
| Company | Cognizant |
| Job Title | SPE – Pharmacovigilance |
| Job ID | 00069891251 |
| Job Category | Technology & Engineering |
| Job Locations | Mumbai, Bangalore, Hyderabad |
| Work Model | Hybrid |
| Work Shift | Day shift |
| Date Published | 25 September 2026 |
| Experience | At least 1 year of exposure to clinical or safety-related documentation |
| Preferred Certification | Pharmacovigilance or drug safety training, such as DIA certification |
Position
SPE – Pharmacovigilance
The selected candidate will support pharmacovigilance operations, including safety case handling, medical data review, adverse event classification, narrative preparation, and timely reporting in accordance with internal procedures and global pharmacovigilance requirements.
Responsibilities
Key responsibilities include:
- Process pharmacovigilance cases and ensure accurate safety data capture.
- Review source documents and clinical data to identify relevant adverse event information.
- Handle spontaneous and solicited adverse event reports.
- Assess case seriousness and expectedness within the scope of experience.
- Prepare medically coherent case narratives and structured ICSR data.
- Support regulatory reporting and electronic submission activities.
- Monitor case processing queues and prioritize urgent reporting timelines.
- Coordinate with clinical operations and quality teams to resolve data inconsistencies.
- Maintain confidential patient information and audit-ready documentation.
- Follow standard operating procedures and global pharmacovigilance guidelines.
- Support periodic safety reviews and contribute to workflow improvements.
Eligibility and Qualifications
Candidates should meet the following requirements:
- At least one year of exposure to clinical or safety-related documentation in pharmaceutical research and development.
- Familiarity with pharmacovigilance case processing, data capture, seriousness assessment, and narrative preparation.
- Foundational understanding of ICSR submission practices.
- Ability to review medical data, adverse event descriptions, and product information accurately.
- Understanding of regulated work environments, confidentiality requirements, and pharmacovigilance procedures.
- Willingness to participate in training and develop knowledge of drug safety and case processing.
Required Skills
- Pharmacovigilance case processing
- Individual Case Safety Report (ICSR) documentation
- Adverse event intake and classification
- Medical data review
- Case narrative preparation
- Seriousness and expectedness assessment
- Regulatory compliance and documentation
- Attention to detail
- Written and verbal communication
- Cross-functional coordination
Certification Requirements
Pharmacovigilance or drug safety certifications from recognized professional organizations, such as DIA, are preferred.
