Location: Budapest, Hungary – Mill park office building

Full-time employment

Hybrid work mode: office attendance once per week

We offer:

·       Competitive salary and benefit package (cafeteria + annual bonus)

·       Training and continuous learning and certification opportunities

·       Chance to be part of a rapidly expanding organization

·       Multilingual, multicultural environment with native colleagues

·       All You Can Move SportPass (at a discounted price)

·       Free medical benefit package

·       Reimbursable language courses

·       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

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.

·       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.