Dutch 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.

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.

Co-ordinate with internal teams to obtain necessary information required for day-to-day operations.

Assist in the training and mentorship of new joiners as necessary.

Willingness to assist team leads or take up ad-hoc operational activities as required

1 year of Pharmacovigilance or relevant clinical experience

Min. B2 spoken and written Dutch and English proficiency

· 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