French speaking Affiliate Pharmacovigilance Associate
Full-time employment
Work location: Budapest
Shift pattern: General
WFO: We are flexible for work from office days. Currently, we are working 2 days in a month from office, and it may evolve to 1/ 2 days in a week depending on HR communication.
We offer:
· Competitive salary and benefit package (cafeteria + annual bonus)
· Training and continuous learning and certification opportunities
· Free medical benefit package
· Reimbursable language courses
· Risk and accident insurance
· Chance to be part of a rapidly expanding organization
· Multilingual, multicultural environment with native colleagues
· All You Can Move SportPass (at a discounted price)
· Team events, company events
· Relocation package
· High value awards and recognitions
Your profile:
- Graduate in Pharmacy or Life Science
- 1 year of Pharmacovigilance or relevant clinical experience
- Excellent spoken and written French and English proficiency
Key Responsibilities:
Responsible for receiving/downloading information from different channels and receiving voice calls for reporting safety information.
Route information/safety reports to appropriate Department (e.g. medical information, quality assurance) as applicable.
Monitoring mailbox, triage for patient safety reports and emails.
Maintaining and archival of emails/source documents and updating shared folders.
Handling of source document and entering data in front-end system as per triage criteria; acknowledge receipt of information.
Obtain consent from reporter to follow up on safety reports.
Assess cases for missing information and follow up attempts until closure.
Check case validity.
Perform initial checks, search database to prevent duplicate entries.
Ensure upfront clarification requests in case of data discrepancy identified in source document.
Enter safety information in front-end system and evaluating the safety information for case seriousness and potential upgrade and downgrade for seriousness in follow up cases, evaluate dechallenge-rechallenge.
Translation & Back Translation of safety information as applicable.
Anonymize/redact source documents and/or AE forms (as applicable).
Responsible for receiving, reviewing and archiving source data records for any missing/discrepant safety information.
Identify discrepancies and maintain email clarifications of discrepancies for SDV.
Perform Health Authority database/registry extraction to retrieve and processes Individual Case Safety Reports.
Document review processes.
Responsible for completion of day-to-day work and process flows within the agreed SLAs
Maintaining data as per customer guidelines.
Work with project quality roles to improve case quality.
Attend training sessions and develop skills and capabilities on an ongoing basis.
Timely completion of assigned trainings and training files.
Co-ordinate with internal teams to obtain necessary information required for day-to-day operations.
Assists in the training and mentorship of new joiners as necessary.
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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.
