SPE-Pharmacovigilance

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

Job summary

Cognizant in Mumbai is seeking a Pharmacovigilance Specialist to contribute to global medicine safety by handling safety data and clinical documentation, supporting compliant case management and timely reporting.

The role operates in a hybrid day shift, collaborating with cross-functional teams to protect patient wellbeing and strengthen public trust in healthcare innovations.

Qualifications

• Experience in pharmaceutical research and development activities with exposure to clinical or safety documentation.
• Familiarity with pharmacovigilance case processing concepts including data capture, seriousness assessment, and narrative preparation.
• Understanding dossier preparation and timely reporting activities under supervision.
• Strong attention to detail when reviewing medical data, adverse event descriptions, and product information.
• Effective written and verbal communication to collaborate with clinical safety and quality teams in a hybrid environment.

Responsibilities

• Perform end to end pharmacovigilance case handling activities for assigned safety reports ensuring accurate data capture, narrative clarity, and consistent application of procedures.
• Review source documents and clinical data to validate medical information and identify safety details for robust risk/benefit evaluation.
• Execute standardized workflows for adverse event intake, classification, and data entry with high data quality and regulatory compliance.
• Conduct medical assessment of individual case safety reports within scope of experience, escalate complex cases to senior reviewers as needed.
• Prepare regulatory compliant ICSRs including narratives and structured data for timely electronic submission to health authorities.
• Support case processing metrics, monitor workloads, and collaborate to meet urgent regulatory timelines and service levels.
• Contextualize reported adverse events within R&D processes to inform signal interpretation and product documentation.
• Coordinate with cross-functional teams to resolve data inconsistencies and obtain missing information for safety records.
• Adhere to SOPs and PV guidelines, complete trainings, and support audit-ready safety systems.
• Contribute to process improvements by sharing observations and assisting implementation of enhancements.

Skills

Pharmacovigilance

Data entry

Narrative writing

Data review

Attention to detail

Communication skills

Education

Bachelor's degree in life sciences

Tools

PV databases

Job description

Job Summary

Contribute to global medicine safety as a specialist in pharmacovigilance focusing on high quality pharmaceutical research and development activities for an international organization. Apply foundational experience in safety data handling and clinical documentation to support compliant case management and timely reporting. Work in a hybrid day shift model collaborating with cross functional teams to protect patient wellbeing and strengthen public trust in healthcare innovations.

Responsibilities

• Perform end to end pharmacovigilance case handling activities for assigned safety reports ensuring accurate data capture narrative clarity and consistent application of internal procedures to support reliable patient safety decisions.


• Review source documents and clinical data from pharmaceutical research and development activities validate medical information and identify relevant safety details that contribute to robust evaluation of product risk and benefit profiles.


• Execute standardized workflows for spontaneous and solicited adverse event intake classification and data entry maintaining high levels of data quality and compliance with global pharmacovigilance regulations and company governance.


• Conduct detailed medical assessment of individual case safety reports within scope of experience confirm event seriousness and expectedness and elevate complex or medically sensitive cases to senior safety reviewers as needed.


• Prepare regulatory compliant individual case safety report outputs including medically coherent narratives and structured data elements to enable timely electronic submission to health authorities and business partners.


• Support the maintenance of case processing metrics by monitoring workload queues prioritizing urgent regulatory timelines and collaborating with colleagues so that safety reports are completed within agreed service levels.


• Apply knowledge of pharmaceutical research and development processes to contextualize reported adverse events recognize clinically relevant product information and contribute to accurate interpretation of safety signals.


• Coordinate with cross functional teams in clinical operations and quality units to resolve data inconsistencies obtain missing information and ensure that safety records remain aligned with current product and study documentation.


• Follow hybrid work model expectations by maintaining clear communication channels using digital collaboration tools effectively and safeguarding confidential safety data in both on site and remote work settings.


• Adhere to internal standard operating procedures and global pharmacovigilance guidelines by completing mandatory trainings documenting case handling steps thoroughly and supporting audit ready safety systems.


• Contribute to continuous improvement of case processing practices by sharing operational observations suggesting refinements to templates or workflows and supporting implementation of approved process enhancements.


• Support periodic review activities and safety summaries by providing reliable case level outputs that help medical safety experts evaluate trends and inform risk mitigation measures for patients and healthcare systems.


• Engage in knowledge building activities for pharmacovigilance and pharmaceutical research topics by participating in team discussions and learning sessions thereby strengthening personal expertise and overall team capability.

Qualifications

• Demonstrate practical experience in pharmaceutical research and development activities with at least one year of exposure to clinical or safety related documentation that supports accurate medical data interpretation.


• Show familiarity with pharmacovigilance case processing concepts including data capture seriousness assessment and narrative preparation to enable effective handling of individual case safety reports.


• Apply foundational understanding of individual case safety report submission practices by following structured steps for dossier preparation and supporting timely reporting activities under supervision.


• Exhibit strong attention to detail in reviewing medical data adverse event descriptions and product information ensuring that safety records are complete consistent and suitable for regulatory use.


• Utilize effective written and verbal communication skills to collaborate with clinical safety and quality teams in a hybrid work environment while maintaining clear documentation of case related decisions.


• Demonstrate ability to work in a regulated environment by following pharmacovigilance procedures maintaining confidentiality of patient information and supporting compliance with global health authority expectations.


• Display motivation to expand knowledge in pharmacovigilance case processing and related safety sciences by engaging in training seeking feedback from experienced colleagues and applying learning to day to day tasks.

Certifications Required

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