SPE-Pharmacovigilance, MUMBAI, Maharashtra, India

Job Summary

Serve as a specialist professional in pharmacovigilance within a hybrid work model supporting pharma research and development activities focused on the safe and effective use of medicinal products. Contribute to data driven safety evaluation and collaborate across functions to enhance patient safety outcomes and regulatory compliance.

Responsibilities

Perform end to end case related pharmacovigilance activities that support ongoing pharma research and development and help ensure timely safety reporting to regulatory bodies

Review available clinical and post marketing safety information to identify potential safety signals and contribute to risk assessment activities that protect patients

Analyze safety data using company systems to detect trends or patterns and escalate relevant findings to medical safety experts for further evaluation

Document all safety case handling steps with clear and accurate narratives that enable transparent audits and inspections by internal and external stakeholders

Collaborate with cross functional research and development teams to integrate safety insights into study design and product lifecycle decisions that advance therapeutic innovation

Coordinate with quality and compliance teams to follow current pharmacovigilance procedures and support continuous improvement of standard operating processes

Support preparation of safety sections for regulatory submissions and periodic reports so that product safety profiles are clearly communicated and well justified

Contribute to knowledge sharing sessions with peers to promote consistent case processing practices and strengthen the overall pharmacovigilance capability of the organization

Engage with internal technology and data teams to refine pharmacovigilance tools so that safety data capture and retrieval become more efficient and reliable

Participate in internal audits or readiness activities by providing case related documentation and clarifications that demonstrate strong adherence to pharmacovigilance requirements

Adapt work practices to a hybrid model by using digital collaboration platforms that maintain continuity of pharmacovigilance operations across onsite and remote settings

Support broader company goals by transforming safety data into meaningful insights that guide responsible use of medicines and create a positive impact on public health

Manage personal workload within day shift expectations to ensure all assigned safety activities and timelines are met without the need for travel

Qualifications

Possess a degree in life sciences pharmacy medicine or a related discipline that provides a solid scientific foundation for evaluating drug safety information

Demonstrate two to four years of focused experience in pharma research and development with direct exposure to pharmacovigilance practices and processes

Apply working knowledge of safety data review tools or databases to manage cases efficiently while maintaining data integrity and traceability

Utilize familiarity with pharmacovigilance data management concepts to support accurate entry reconciliation and retrieval of safety information when required

Exhibit practical understanding of pharmacovigilance case processing steps including intake coding assessment and follow up activities that align with current regulations

Communicate clearly in written and spoken form with global stakeholders to ensure that complex safety issues are documented and discussed in an accessible manner

Show commitment to ongoing learning about evolving pharmacovigilance guidelines and research methodologies so professional skills remain current and adaptable

Certifications Required

Desired certification in pharmacovigilance or drug safety such as a recognized pharmacovigilance professional credential

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.