SPE-Pharmacovigilance, MUMBAI, Maharashtra, India

Job Summary

Serve as a Senior Process Executive in pharmacovigilance within a hybrid work model performing high quality safety case activities that rely on strong pharma research and development experience. Apply structured scientific methods to evaluate safety data support compliant reporting and help protect patient well being while enabling safe and effective use of healthcare products across global markets.

Responsibilities

Perform end to end safety case processing activities by reviewing source documents coding relevant information and preparing case narratives to support accurate and timely pharmacovigilance reporting

Execute medical and scientific assessments of safety data by applying pharma research and development knowledge to identify potential safety issues and trends that may impact patient well being

Maintain consistent data quality in safety databases by performing detailed data entry checks query resolutions and reconciliation activities aligned with sponsor and regulatory expectations

Conduct routine case follow up activities by tracking missing information coordinating with internal teams and updating case records to improve completeness and clinical usefulness of safety data

Apply established pharmacovigilance procedures by adhering to global regulations and internal standard operating processes to minimize compliance risk and support successful client audits

Collaborate with cross functional colleagues in clinical operations medical information and quality units to ensure that safety information flows accurately and supports unified patient safety decisions

Utilize domain exposure in pharmacovigilance data management to interpret coding conventions and data structures that enhance consistency and usability of stored safety information

Contribute to continuous process improvement by suggesting practical changes to templates checklists and workflows that reduce rework and increase case throughput within the day shift schedule

Support preparation of safety metrics and summary reports by extracting key indicators from case data that help client teams monitor performance and identify emerging safety signals

Engage in regular training and knowledge refresh sessions to stay aligned with evolving pharmacovigilance regulations client procedures and best practices in pharma research and development

Adhere to hybrid work and data confidentiality protocols by following secure handling guidelines and using approved systems to protect sensitive health and product information

Communicate clearly with team members and supervisors about workload status data issues and timeline risks to enable proactive planning and reliable delivery for client projects

Contribute to knowledge sharing within the team by documenting case handling nuances and lessons learned that help colleagues manage complex pharmacovigilance scenarios more efficiently

Qualifications

Possess hands on experience in pharma research and development activities that support evidence based evaluation of safety information and enhance scientific rigor in daily pharmacovigilance work

Demonstrate practical exposure or understanding of pharmacovigilance data management processes that involve case intake coding standards and database handling in a regulated environment

Exhibit working knowledge or experience in pharmacovigilance case processing including triage data entry narrative preparation and case closure within agreed timelines

Hold a degree in pharmacy life sciences medicine or a related discipline that provides a strong foundation in drug development principles and clinical research methodology

Show proven ability to interpret clinical and scientific documents such as clinical study reports literature articles and medical records to derive accurate and meaningful safety insights

Display strong written and verbal communication skills that support clear documentation of safety cases and effective collaboration with global stakeholders in a hybrid work setting

Bring two to four years of relevant professional experience in pharmacovigilance clinical research or related safety focused roles that demonstrate readiness for a senior process executive position

Apply structured analytical thinking and attention to detail to maintain high data integrity prevent avoidable errors and support reliable downstream safety analyses for client organizations

Certifications Required

Preferred certifications include Drug Safety and Pharmacovigilance Certificate or Good Clinical Practice Certification

What we offer

The chance to work with impact. Here, you’re empowered to bring your biggest thinking to help our company and clients improve everyday life.
Ownership over your career. Stay at the top of your game through our award-winning learning and development ecosystem. And when your ambitions change or we offer new opportunities, we help you pivot by providing reskilling, on-the-job learning and guidance to find new roles that might be a better fit.
The opportunity to thrive on a high caliber team with heart. We celebrate each other’s experiences and perspectives and promote a sense of belonging through our affinity groups and diversity and inclusion initiatives.
A comprehensive total rewards package, including a competitive salary and a pension plan with matching contributions.
Flexible health and financial benefits to support you and your eligible dependents—from day one.
True work-life balance. Be at your best through paid time off, flexible work arrangements, volunteering opportunities, social events, and so much more.

About us
Cognizant (Nasdaq: CTSH) is an AI Builder and technology services provider, building the bridge between AI investment and enterprise value by building full-stack AI solutions for our clients. Our deep industry, process and engineering expertise enables us to build an organization’s unique context into technology systems that amplify human potential, realize tangible returns and keep global enterprises ahead in a fast-changing world. See how at www.cognizant.com or @cognizant.

Other employment-related information
Cognizant is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, provincial or local laws.

If you have a disability that requires reasonable accommodation to search for a job opening or submit an application, please email [email protected] with your request and contact information.

Language requirements vary depending on roles, but we ask that all candidates have basic English proficiency for company-wide communications purposes. For roles based in Quebec, professional English proficiency is required, as you’ll deliver services to and collaborate with stakeholders outside the province who may not speak French.