Dutch Speaking Pharmacovigilance Associate Budapest

Dutch Speaking Pharmacovigilance Associate
Budapest

Our American multinational partner company, which is supporting its clients in different areas, is looking for Dutch speakers, fresh starters as well as experienced Pharma/Life Sciences graduates for their team.

Benefits :

Competitive salary and cafeteria benefits; free sport allowance (near the office buildings), All You Can Move SportPass (at a discounted price), medical benefits and other perks

Risk and accident insurance

Chance to be part of a rapidly expanding organization

Training and continuous learning and certification opportunities

Multilingual environment, native colleagues

Pleasant and inspiring working atmosphere with multicultural community and state-of-the-art technologies

Easy to access location and modern office building (easy to reach from city centre, 10-15 minute commute)

Reimbursable language courses

Team events and Company events (cool and youthful parties with team-games)

High value awards and recognitions, annual bonus for top performers, and annual salary review

Your tasks will be:

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.

Requirements:

Graduate in Pharmacy or Life Science

1 year of Pharmacovigilance or relevant clinical experience

Excellent spoken and written Dutch and English proficiency