Cognizant Hiring for SME – Medical Safety Pharmacovigilance | Mumbai, Bangalore & Hyderabad

Cognizant is inviting applications for the position of SME – Medical Safety across Mumbai, Bangalore and Hyderabad. The role focuses on medical safety assessments, pharmacovigilance, clinical and nonclinical data interpretation, safety signal detection, and medical review activities within a global pharmaceutical research and development environment.

Candidates with 2–3 years of experience in pharmaceutical R&D, medical safety, clinical studies or pharmacovigilance-related activities can apply.

Job Details

Position

SME – Medical Safety

The selected candidate will serve as a subject matter expert in medical safety, supporting safety data interpretation, risk assessments, medical reviews, signal detection and regulatory documentation throughout the product development lifecycle.

Key Responsibilities

• Interpret clinical and nonclinical safety data to identify and document emerging safety signals.
• Conduct medical safety assessments of individual and aggregate safety cases from clinical trials and post-marketing sources.
• Evaluate adverse event seriousness, causality and potential patient safety impact.
• Provide medical safety inputs for study protocols, informed consent documents and safety monitoring plans.
• Review safety-related sections of clinical and regulatory documents, including risk management narratives and summary reports.
• Support signal detection by analysing safety trends and preparing safety data summaries.
• Coordinate with pharmacovigilance and clinical operations teams to resolve case-related discrepancies.
• Prepare responses to safety-related queries from regulatory authorities and internal stakeholders.
• Maintain documentation of medical safety decisions, review outcomes and assessment rationales.
• Participate in cross-functional meetings and contribute to improvements in medical safety procedures.

Eligibility and Qualifications

• 2–3 years of hands-on experience in pharmaceutical research and development, particularly in safety-related clinical study or product development activities.
• Practical understanding of adverse event evaluation, seriousness assessment and causality assessment.
• Working knowledge of pharmacovigilance processes and medical review practices.
• Exposure to PV medical review activities.
• Experience with electronic data capture (EDC) tools or safety databases.
• Ability to interpret medical data and prepare structured safety summaries and medical narratives.
• Understanding of ethical medical practices, patient safety principles and regulatory expectations.

Required Skills

• Medical Safety Assessment
• Pharmacovigilance (PV)
• Adverse Event Evaluation
• Seriousness and Causality Assessment
• Clinical Safety Data Review
• Signal Detection and Safety Monitoring
• Medical Review
• Clinical Research and Pharmaceutical R&D
• Regulatory Safety Documentation
• EDC Tools and Safety Databases
• Analytical and Critical Thinking
• Written and Verbal Communication

Preferred Certification

Certification in pharmacovigilance or drug safety, such as Pharmacovigilance Professional Certification or an equivalent qualification, is preferred.