Job Summary
This hybrid role is for a specialist professional in pharmacovigilance with experience in pharma research and development focused on ensuring high quality safety data and regulatory compliance for global markets. The role involves daily case review safety data analysis and collaboration with cross functional teams to support safer therapies for patients worldwide.
Responsibilities
- Perform pharmacovigilance case intake activities by reviewing source documents verifying completeness of safety information and ensuring accurate capture of relevant medical data to maintain high quality case processing standards.
- Execute detailed case assessment activities by evaluating seriousness causality and expectedness based on clinical and scientific judgment to support consistent safety signal interpretation.
- Document adverse events and product complaints in safety databases by entering structured and narrative information with strong attention to accuracy and consistency to comply with internal and regulatory requirements.
- Collaborate with cross functional colleagues in clinical development medical affairs and regulatory functions by sharing safety insights to support informed benefit risk evaluations for investigational and marketed products.
- Apply pharma research and development knowledge by interpreting clinical protocols investigator brochures and development safety update reports to ensure case evaluation aligns with project objectives.
- Conduct ongoing case follow up by tracking pending information coordinating with partners and updating records to maintain complete and reliable pharmacovigilance data sets.
- Review safety data outputs such as line listings and summary tables by identifying inconsistencies and trends to support aggregate safety reporting and risk management activities.
- Support process improvement initiatives by identifying recurring issues in data entry documentation and case routing to enhance overall efficiency and quality of pharmacovigilance operations.
- Ensure strict adherence to global regulations and internal standard operating procedures by staying current with evolving pharmacovigilance guidance and applying it consistently during daily tasks.
- Utilize pharmacovigilance systems and tools by performing data entry query resolution and quality checks to maintain data integrity and traceability across the safety lifecycle.
- Coordinate with vendor or partner teams where applicable by clarifying case requirements sharing feedback and supporting smooth handoffs to achieve timely and compliant case closure.
- Participate in audits and inspections by providing clear documentation case histories and process explanations to demonstrate robust compliance and quality controls.
- Contribute to a culture of patient safety by highlighting potential safety concerns promoting responsible data practices and supporting improved health outcomes for individuals and communities.
Qualifications
- Possess a degree in pharmacy life sciences medicine or a related scientific discipline with practical experience in pharma research and development supporting clinical or safety activities.
- Demonstrate two to four years of hands on pharmacovigilance or drug safety experience with proven exposure to case processing workflows and safety database usage.
- Exhibit working knowledge of pharmacovigilance data management practices by understanding coding conventions dictionary usage and principles of structured medical data capture.
- Show familiarity with PV case processing steps including intake triage data entry medical review support and case closure while maintaining timelines and quality requirements.
- Display strong understanding of regulatory expectations for safety reporting including key concepts related to seriousness expectedness and causality assessment.
- Utilize effective communication skills to collaborate with global teams clarify medical details and document case summaries in a clear and concise manner.
- Apply strong analytical and problem solving skills to investigate discrepancies resolve data issues and contribute to process enhancements in pharmacovigilance operations.
- Maintain high attention to detail and quality focus by consistently following standard operating procedures work instructions and documentation practices.
- Leverage working knowledge of hybrid work environments by effectively managing time virtual collaboration tools and secure handling of safety information while working from different locations.
Certifications Required
Preferred certifications include pharmacovigilance or drug safety credentials such as a pharmacovigilance certification from a recognized life science institute.
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.
