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.
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.
Responsible for completion of day-to-day work and process flows within the agreed SLAs
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.
Requirements
Experience: 0 to 2 years of Pharmacovigilance or relevant Clinical experience or translation experience in Medical Documents is preferred
Language Capability: Good spoken and written German or Dutch proficiency (level B2 minimum or equivalent) or Native speaker and good spoken and written English proficiency
Minimal Education Qualification: Life Sciences or Pharmacy or Medical degree
What we offer
Competitive salary and cafeteria benefits; All You Can Move SportPass (at a discounted price)
Home office (4 days/week)
Medical 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
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
Relocation package available
Company info
Our partner is a multinational SSC company, working on a pharmaceutical project for an American pharmaceutical company, located in Budapest (9th district).