SME-Medical Safety

Cognizant; Navi Mumbai; Hybrid; INR 900,000 - 1,500,000; Full time

Job summary

Cognizant Technology Solutions Corporation is seeking a subject matter expert in medical safety to support global pharmaceutical product development. You will apply R&D knowledge to manage safety data, perform risk assessments, and provide medical review across cross-functional teams in a hybrid work model with day-shift engagement.

The role emphasizes signaling safety issues, preparing concise narratives, and ensuring robust safety documentation aligned with regulatory expectations.

Qualifications

• 2–3 years hands-on safety experience in pharma R&D or clinical studies.
• Understanding of adverse event evaluation, seriousness, and causality.
• Familiarity with PV processes and medical review activities.
• Ability to summarize safety insights for nonmedical colleagues.
• Strong written and verbal communication for safety narratives.
• Comfortable in a hybrid, day-shift work environment.
• Experience with PV data systems to retrieve and document case details.
• Commitment to ethical medical practice and patient safety.

Responsibilities

• Interpret data from pharma R&D to identify safety signals.
• Conduct risk assessments and document safety evaluations clearly.
• Provide medical safety input on study protocols and monitoring plans.
• Refine safety sections of core documents and risk narratives.
• Prepare safety data summaries and regulatory responses.
• Coordinate with PV and clinical ops to resolve data issues.
• Support audit-ready documentation and traceability of decisions.
• Engage in day-shift cross-functional safety discussions.

Skills

Clinical safety

Pharma R&D

Adverse events evaluation

Pharmacovigilance processes

Medical data interpretation

Medical narratives

Cross-functional collaboration

Hybrid work experience

Tools

Electronic data capture tools

Safety databases

Job description

Job Summary

Serve as a subject matter expert in medical safety within a global pharmaceutical environment applying research and development knowledge to support safe and effective product development. Contribute to risk assessment safety data interpretation and medical review activities in a hybrid work model ensuring day shift engagement and strong collaboration across cross functional teams.

Responsibilities

• Apply medical safety expertise to interpret clinical and nonclinical data from pharma research and development activities ensuring that emerging safety signals are identified and documented with clarity and consistency across assigned products.
• Perform structured medical safety assessments of individual and aggregate case data from clinical trials and postmarketing sources focusing on accurate evaluation of seriousness causality and potential impact on patient safety and regulatory commitments.
• Collaborate with cross functional teams in research and development to provide timely medical safety input on study protocols informed consent documents and safety monitoring plans supporting robust risk mitigation strategies for ongoing projects.
• Review and refine safety related sections of core clinical and regulatory documents including risk management narratives and summary reports ensuring that medical interpretations are scientifically sound and aligned with company safety standards.
• Support signal detection activities by analyzing safety trends preparing concise summaries of safety data and recommending follow up actions that promote continuous improvement in product safety profiles.
• Coordinate with pharmacovigilance and clinical operations partners to clarify case details resolve data inconsistencies and enhance the overall quality and completeness of safety information captured in internal systems.
• Contribute to the preparation of responses for safety related queries from regulatory authorities and internal stakeholders ensuring that explanations are medically justified data driven and aligned with global safety practices.
• Maintain accurate documentation of medical safety decisions rationales and review outcomes in designated tools supporting audit readiness and transparent traceability of safety evaluations across the product lifecycle.
• Participate in cross functional meetings during the day shift to discuss safety topics share insights from ongoing reviews and ensure that safety considerations are integrated into key development and commercialization decisions.
• Support development and refinement of internal medical safety procedures by providing feedback from practical case handling experience helping to streamline workflows and enhance overall efficiency in safety review activities.
• Engage in hybrid work model collaboration using digital communication tools maintaining strong partnerships with global colleagues while ensuring timely delivery of safety assessments and documentation.
• Contribute to the company purpose of bringing safe and effective therapies to individuals and communities by rigorously applying medical judgment to safety data and highlighting potential risks that may affect public health outcomes.
• Pursue continuous learning in medical safety research and development practices and evolving pharmacovigilance requirements to keep safety evaluations current and to support innovative solutions that improve societal health.

Qualifications

• Demonstrate solid experience in pharma research and development with two to three years of hands on involvement in safety related aspects of clinical studies or product development activities.
• Apply practical understanding of adverse event evaluation seriousness assessment and causality reasoning gained from previous roles in medical safety or closely related research functions.
• Utilize working knowledge of pharmacovigilance processes and medical review practices including exposure to PV medical review activities to support high quality case assessments and signal evaluations.
• Employ strong analytical and critical thinking capabilities to interpret complex medical data sets summarize key safety insights and communicate findings clearly to nonmedical colleagues.
• Use effective written and verbal communication skills to prepare structured safety summaries medical narratives and responses for internal and external stakeholders in a concise and comprehensible manner.
• Operate comfortably in a hybrid work environment and day shift setting managing time and tasks independently while staying fully engaged with remote and onsite team interactions.
• Draw on experience with standard safety and clinical data systems such as electronic data capture tools or safety databases to retrieve information verify case details and support accurate documentation.
• Exhibit commitment to ethical medical practice and patient safety by following internal procedures regulatory expectations and scientific principles in every aspect of safety review and documentation.

Certifications Required

Preferred certification in pharmacovigilance or drug safety such as Pharmacovigilance Professional Certification or equivalent.