Dutch-speaking Pharmacovigilance Associate Budapest

Dutch-speaking Pharmacovigilance Associate
Budapest

Your new company

We are looking for a Dutch-speaking Pharmacovigilance Associate for our multinational SSC partner company in Budapest.

Your 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.

What you need to succeed

University/College degree from Life Sciences, Pharmaceutical or Medical field is a must-have

Language skills: at least B2 level in Dutch and English

Previous experience in a similar role or at a pharmaceutical company is an advantage

What you can expect from our partner

Competitive salary

Annual bonus

Risk and accident insurance

Cafeteria

Welcoming and open team

Fitness package

Home-office (4 day/week)

Reimbursable language courses

Fast-paced, growing company

What you need to do now

In case you find this opportunity interesting, press on the ’Apply’ button and send us your fresh CV.