Cognizant
Cognizant is hiring for the position of SPE – Pharmacovigilance in India. The role is suitable for professionals with experience in pharmacovigilance, clinical documentation, safety data handling, and pharmaceutical research & development activities.
Job Details
- Company: Cognizant
- Position: SPE – Pharmacovigilance
- Job ID: 00069891251
- Locations: Mumbai / Bangalore / Hyderabad, India
- Job Type: Full-Time
- Work Model: Hybrid
- Work Shift: Day Shift
- Date Published: 25 September 2026
- Experience: Minimum 1 year of relevant pharmaceutical research, clinical or safety documentation experience
- Industry: Pharmaceutical / Healthcare / Life Sciences
Job Summary
The selected candidate will contribute to global medicine safety activities by supporting pharmacovigilance case processing and pharmaceutical research and development activities for an international organization.
The role involves handling safety data, reviewing clinical documentation, preparing individual case safety reports, and ensuring compliance with internal procedures and global pharmacovigilance requirements.
The position also involves collaboration with cross-functional teams to maintain accurate safety records and support timely reporting.
Key Responsibilities
- Perform end-to-end pharmacovigilance case handling for assigned safety reports.
- Review source documents and clinical data to identify relevant safety information.
- Process spontaneous and solicited adverse event reports.
- Perform data entry, case classification, and quality checks.
- Conduct medical assessment of individual case safety reports within the scope of experience.
- Assess case seriousness and expectedness and escalate complex cases when required.
- Prepare medically coherent case narratives and regulatory-compliant safety report outputs.
- Support timely processing of cases according to regulatory timelines and service-level requirements.
- Monitor workload queues and prioritize urgent safety reports.
- Coordinate with clinical, safety, quality, and other cross-functional teams.
- Resolve data inconsistencies and obtain missing information.
- Follow pharmacovigilance SOPs, global guidelines, and company procedures.
- Maintain confidentiality of patient and safety information.
- Participate in audits, training, periodic reviews, and process improvement activities.
- Support safety summaries and case-level data used by medical safety teams for trend evaluation and risk mitigation.
Eligibility & Qualifications
Candidates should have:
- At least 1 year of experience in pharmaceutical research and development activities, clinical documentation, or safety-related documentation.
- Understanding of pharmacovigilance case processing concepts.
- Knowledge of adverse event data capture and classification.
- Familiarity with seriousness assessment and narrative preparation.
- Basic understanding of ICSR submission practices.
- Strong attention to detail while reviewing medical and safety information.
- Good written and verbal communication skills.
- Ability to work in a regulated pharmaceutical/healthcare environment.
- Understanding of confidentiality requirements related to patient safety information.
- Willingness to learn and develop expertise in pharmacovigilance and drug safety.
Preferred Certification
Certification or training in Pharmacovigilance / Drug Safety from recognized professional organizations such as DIA or similar industry bodies is preferred.
Skills Required
Core Skills:
- Pharmacovigilance
- Drug Safety
- Case Processing
- ICSR
- Adverse Event Reporting
- Safety Data Management
- Medical Documentation
- Clinical Documentation
- Case Narrative Writing
- Seriousness & Expectedness Assessment
- Regulatory Compliance
- SOP Compliance
- Quality Review
- Attention to Detail
Who Can Apply?
This opportunity may be suitable for professionals with a background in Pharmacovigilance, Drug Safety, Clinical Research, Life Sciences, Pharmacy, or related pharmaceutical functions who have relevant experience in safety or clinical documentation.
How to Apply
Interested candidates should search for Cognizant Job ID 00069891251 – SPE Pharmacovigilance on Cognizant’s official careers portal and submit their application through the company’s official recruitment process.
To apply for this job please visit careers.cognizant.com.

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