Cognizant is hiring for the position of SPE-Pharmacovigilance across Mumbai, Bangalore, and Hyderabad. The role involves pharmacovigilance case processing, clinical data review, safety documentation, regulatory reporting, and collaboration with clinical safety and quality teams.

Job Details

Position

SPE-Pharmacovigilance

The role focuses on global medicine safety, including pharmacovigilance case management, safety data handling, clinical documentation, regulatory reporting, and pharmaceutical research and development activities.

Responsibilities

• Perform end-to-end pharmacovigilance case handling, including data capture and narrative preparation.
• Review source documents and clinical data to identify relevant safety information.
• Handle spontaneous and solicited adverse event intake, classification, and data entry.
• Conduct medical assessment of individual case safety reports and escalate complex cases when required.
• Prepare regulatory-compliant individual case safety report outputs for electronic submission.
• Monitor case processing workloads and prioritize urgent regulatory timelines.
• Coordinate with clinical operations and quality teams to resolve data inconsistencies and obtain missing information.
• Follow standard operating procedures and global pharmacovigilance guidelines.
• Maintain confidentiality of safety and patient information.
• Support continuous improvement of case processing practices, templates, and workflows.
• Support periodic reviews and safety summaries with reliable case-level outputs.
• Participate in pharmacovigilance and pharmaceutical research knowledge-building activities.

Eligibility / Qualifications

• At least 1 year of experience in pharmaceutical research and development activities with exposure to clinical or safety-related documentation.
• Familiarity with pharmacovigilance case processing, including data capture, seriousness assessment, and narrative preparation.
• Foundational understanding of individual case safety report submission practices and dossier preparation.
• Strong attention to detail when reviewing medical data, adverse event descriptions, and product information.
• Effective written and verbal communication skills.
• Ability to work in a regulated environment and follow pharmacovigilance procedures.
• Ability to maintain confidentiality of patient information.
• Motivation to develop knowledge in pharmacovigilance case processing and related safety sciences.

Preferred Certification

Preferred certifications include pharmacovigilance or drug safety training from recognized industry bodies such as DIA or similar professional organizations.

Required Skills

• Pharmacovigilance Case Processing
• Safety Data Handling
• Clinical Documentation
• Individual Case Safety Reports
• Medical Data Interpretation
• Narrative Preparation
• Dossier Preparation
• Regulatory Reporting
• Clinical Operations
• Standard Operating Procedures
• Written and Verbal Communication

Application Details

Application Link