French speaking Affiliate Pharmacovigilance Associate @ Reed Recruitment Hungary Budapest

French speaking Affiliate Pharmacovigilance Associate @ Reed Recruitment Hungary
Budapest
Budapest, Budapest, HU

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.