SPE-Pharmacovigilance

1. Triage & intake of ICSRs in ARGUS databases within agreed timelines
2. Download and monitor valid ICSRs from EudraVigilance (EV)- or any other sources
3. Process literature, spontaneous, clinical trial, and solicited cases
4. Search for valid ICSRs in Literature search tools
5. Generate reports and submit to health authorities and business partners
6. Enter serious and non-serious ICSRs in ARGUS per client SOP and WI with high accuracy
7. Code events, indications, patient history using MedDRA
8. Code suspect products, amend narratives, and label events
9. Obtain follow-up information for all cases per applicable guidelines
10. Submit processed cases to regulatory authorities and distribute reports to Partners
11. Communicate effectively with client stakeholders and internal teams
12. Attend all internal and client trainings to ensure guideline compliance
13. Ensure adherence to regulatory requirements and industry standards in all aspects of pharmacovigilance and safety operations.
14. Assist in the development and maintenance of standard operating procedures to ensure consistency and quality in process execution.
15. Support training and development initiatives to enhance team capabilities and knowledge in pharmacovigilance and safety operations.
16. Utilize technical skills to troubleshoot and resolve process-related issues, minimizing disruptions and ensuring smooth operations.
17. Engage in rotational shifts to provide consistent support and coverage across different time zones.

1. Bachelor’s / Master’s degree in pharmacy.
2. Minimum 1+ years relevant work experience in case processing activities.
3. Experience in Cardiovascular (CVS), Neuroscience (CNS), Oncology, Immunology therapeutic areas and Gene Therapy will be an added advantage. Experience with global pharma sponsor will be preferred.
4. In-depth knowledge and understanding of applicable global, regional, and local regulatory requirements, including Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and International Conference of Harmonization (ICH) guidelines, SOPs.
5. Excellent organizational and time management skills.
6. Proficiency in Microsoft Office and web-based applications (e.g., Word, Excel, PowerPoint).
7. Good knowledge of medical terminology.
8. Proven ability to follow instructions and guidelines, work independently, and take initiative.
9. Excellent attention to detail and accuracy in maintaining high-quality standards.
10. Strong written and verbal communication skills.

About Cognizant: 
Cognizant (Nasdaq: CTSH) is an AI Builder and technology services provider, bridging the gap 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, drive tangible outcomes and keep global enterprises ahead in a fast-changing world. See how at cognizant.ai or @cognizant.

Additional employment information
Compensation information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.

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.

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.

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