Pharmacovigilance Associate - Dutch Speaking-Budapest (Remote)Amsterdam, North Holland Consulting
Pharmacovigilance Associate - Dutch Speaking - Training Provided - Budapest - Remote
We have received instructions from one of the world's most innovative Medical firms for a Pharmacovigilance Associate. This exciting and challenging project is happening in a beautiful and vibrant city in Hungary and will provide long term (12+ months) job continuity and lots of job satisfaction.
- Responsible for receiving/Downloading information from Email/SharePoint, receiving call for Adverse Event, Medical inquiry (MI), Product complaint (PC).
- Route information/safety reports to appropriate Department viz. Medical inquiry (MI), Product complaint (PC).
- Monitoring mailbox, triage for patient safety reports and emails.
- Maintaining and archival of emails/source documents and updating SharePoint/folder.
- Handling of source document and entering data in client tracking system as per triage criteria. Acknowledge receipt of information as defined by client.
- Obtain consent from reporter for follow up report.
- Assess cases for missing information and initiate Follow up Query Letter using the proper letter format and tracking the follow up attempts till the closure of follow up.
- Check Case Validity as defined by client.
- Perform initial checks, search database to prevent duplicate entries.
- Ensure that upfront clarification requested in case of data discrepancy in source document.
- Enter safety information in client system and evaluating the safety information for case seriousness and potential upgrade and downgrade for seriousness in follow up cases, evaluate dechallenge-rechallenge.
- Patient Support Program - Source Data Verification (SDV); obtain reports from vendor and reconcile data with client application.
- Available after-hours to support the project for operational coverage.
- Translation & Back Translation of patient safety reports within the client SLA.
Required Key Skills and Experience:
Graduate in Pharmacy or Life-Science
Strong preference of 1 year of Pharmacovigilance or relevant Clinical experience
- Excellent spoken and written English proficiency (level B2 CEFR minimum or equivalent preferred)
This is a critical position, interviews are taking place this week so spit-spot and contact me if you would like to be submitted or even a for a confidential chat.
Empiric is one of the fastest-growing technology and transformation recruitment agency's specialising in data, digital, cloud and security. We supply technology and change recruitment services to businesses looking for both contract and permanent professionals. We are committed to delivering more female candidates and those from minority backgrounds and be instrumental in changing the gender and diversity imbalance within the tech sector.