Cognizant is hiring for the position of SPE-Pharmacovigilance in Mumbai. The role focuses on pharmacovigilance case processing, clinical data review, safety documentation, regulatory reporting, and collaboration with cross-functional teams in a pharmaceutical research and development environment.

Job Details

Position

SPE-Pharmacovigilance

The position involves handling pharmacovigilance cases, reviewing clinical and medical information, preparing safety documentation, supporting regulatory reporting, and maintaining compliance with pharmacovigilance procedures.

Responsibilities

• Perform end-to-end pharmacovigilance case handling, including accurate 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.
• Collaborate with clinical operations and quality teams to resolve data inconsistencies and obtain missing information.
• Follow standard operating procedures, pharmacovigilance guidelines, mandatory training requirements, and confidentiality requirements.
• Support continuous improvement of case processing workflows and templates.
• Provide reliable case-level outputs for periodic reviews and safety summaries.

Eligibility / Qualifications

• 1–2 years 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 while maintaining patient information confidentiality.
• Interest in developing knowledge of 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
• Dossier Preparation
• Clinical Documentation
• Clinical Research
• Pharmaceutical Research
• Data Interpretation
• Clinical Operations
• Standard Operating Procedures
• Process Enhancement
• Communication Skills

How To Apply

Application Link