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.
CogHU103
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.
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.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.
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, state or local laws.
