TM-Pharmacovigilance

Cognizant; Navi Mumbai; Hybrid; INR 600,000 - 900,000; Full time

Job summary

Cognizant Technology Solutions Corporation in Navi Mumbai invites a pharmacovigilance professional to manage end-to-end safety operations for global pharmaceutical clients. The role blends pharma R&D knowledge with compliant safety data handling in a hybrid work model to deliver high-quality case processing and safety documentation.

You will oversee intake evaluation and closure, coordinate with medical reviewers and data partners, monitor KPIs, drive process improvements, and mentor junior

Qualifications

• Substantial pharma R&D experience applying clinical data to safety information.
• Experience with pharmacovigilance case processing and safety narratives.
• Graduate or postgraduate degree in pharmacy, life sciences, medicine, or related field.
• Strong analytical and problem-solving skills.
• Clear written and spoken communication with global stakeholders.
• Proficiency with safety databases and office tools.
• Ability to adapt to a hybrid work model and maintain data security.
• Up-to-date knowledge of pharmacovigilance trends and regulatory expectations.

Responsibilities

• Oversee end-to-end pharmacovigilance operations ensuring timely regulatory compliant case handling.
• Coordinate cross-functional safety data interpretation across teams.
• Drive process improvements to enhance quality and efficiency.
• Monitor KPIs and quality metrics, reporting actionable insights.
• Support audit readiness and maintain SOP compliance.
• Collaborate with medical reviewers and data management on case assessments.
• Provide training and mentor junior staff in safety data handling.
• Ensure safety deliverables meet global regulatory requirements.

Skills

Pharmacovigilance

Clinical data interpretation

Regulatory awareness

Communication

Education

Pharmacy or Life Sciences degree

Tools

Safety databases

MS Office

Job description

Job Summary

This role focuses on pharmacovigilance delivery for global pharmaceutical clients by managing end to end safety operations in a hybrid work model while using deep pharma research and development expertise. The professional will ensure compliant safety data handling process optimization quality oversight and continuous improvement across case processing and allied safety workflows supporting safer therapies for patients worldwide.

Responsibilities

• Manage end to end pharmacovigilance operations for assigned clients by overseeing case intake evaluation documentation and closure while ensuring regulatory compliant timelines are consistently met.
• Coordinate cross functional collaboration between pharma research and development teams and safety operations teams to ensure consistent interpretation and integration of safety data across clinical and post marketing activities.
• Drive continuous improvement initiatives across pharmacovigilance workflows by identifying process gaps proposing pragmatic enhancements and supporting implementation to improve quality and operational efficiency.
• Monitor key performance indicators and quality metrics for pharmacovigilance activities by preparing regular reports and using insights to recommend corrective and preventive actions.
• Guide teams in applying pharma research and development knowledge to safety cases by ensuring that clinical context study design details and investigational product information are accurately reflected in safety documentation.
• Review complex safety cases and narratives by validating medical and scientific accuracy consistency with source data and alignment with applicable regulations and internal procedures.
• Collaborate with medical reviewers safety physicians and data management partners by supporting thorough assessment of case seriousness expectedness and benefit risk implications.
• Support audit and inspection readiness activities by maintaining documentation discipline responding to queries and promoting adherence to standard operating procedures and work instructions.
• Coordinate with technology and data teams to optimize case processing tools by providing functional feedback testing enhancements and promoting user adoption in day to day operations.
• Ensure strong stakeholder communication by providing clear status updates discussing risk areas proactively and aligning expectations regarding deliverables and timelines.
• Train and mentor junior pharmacovigilance professionals by sharing domain knowledge explaining pharma research and development concepts and reinforcing best practices in safety data handling.
• Apply knowledge of global regulatory frameworks for pharmacovigilance by ensuring that all safety deliverables meet the requirements of major health authorities and client specific standards.
• Support organizational purpose by contributing to safer medicines for patients through accurate timely and reliable safety data processing and promoting a culture of quality and accountability.

Qualifications

• Possess substantial experience in pharma research and development by applying clinical and scientific understanding to interpret study data investigational products and patient safety information in routine activities.
• Demonstrate proven exposure to pharmacovigilance case processing by handling or reviewing safety cases narratives and follow up activities even if not as a primary responsibility.
• Hold a graduate or postgraduate degree in pharmacy life sciences medicine or a related discipline that provides sound understanding of drug development and human biology.
• Apply strong analytical and problem solving skills by evaluating complex case information identifying inconsistencies and proposing practical resolutions within established timelines.
• Communicate clearly in written and spoken form by preparing structured safety documentation concise emails and collaborative discussions with global stakeholders.
• Utilize proficiency with common safety databases and office productivity tools by entering reviewing and tracking case data as well as preparing reports and presentations.
• Adapt effectively to a hybrid work model by managing time independently maintaining productivity and ensuring secure handling of sensitive safety and clinical information.
• Maintain up to date understanding of emerging pharmacovigilance trends regulatory expectations and industry practices by engaging in continuous learning and applying new knowledge in daily work.

Certifications Required

Preferred certifications include pharmacovigilance certification from DIA or equivalent and advanced training in clinical research or drug safety.