Position Overview:
We are seeking a German-speaking Affiliate Pharmacovigilance QC Associate for a full-time role based in Budapest, Hungary. This position offers a full remote work mode, requiring office attendance once per month.
What We Offer:
Your Profile:
Responsibilities:
We are seeking a German-speaking Affiliate Pharmacovigilance QC Associate for a full-time role based in Budapest, Hungary. This position offers a full remote work mode, requiring office attendance once per month.
What We Offer:
- Competitive salary and benefits package, including cafeteria and annual bonus
- Opportunities for training, continuous learning, and certification
- A chance to be part of a rapidly expanding organization
- A multilingual, multicultural environment with native colleagues
- Discounted All You Can Move SportPass
- Free medical benefit package
- Reimbursable language courses
- Team and company events
- Relocation package
- High-value awards and recognitions
Your Profile:
- At least 1 year of pharmacovigilance or relevant clinical experience
- Excellent proficiency in spoken and written German and English
Responsibilities:
- Receive and download information from various channels and handle voice calls for reporting safety information
- Route information and safety reports to the appropriate departments
- Monitor mailbox, triage patient safety reports and emails
- Maintain and archive emails/source documents and update shared folders
- Handle source documents and enter data into the front-end system as per triage criteria
- Obtain consent from reporters to follow up on safety reports
- Assess cases for missing information and follow up until closure
- Check case validity and perform initial checks to prevent duplicate entries
- Ensure clarification requests in case of data discrepancies
- Enter safety information into the system and evaluate for case seriousness
- Translate and back-translate safety information as needed
- Review and archive source data records for any missing or discrepant safety information
- Identify discrepancies and maintain email clarifications for SDV
- Extract and process Individual Case Safety Reports from Health Authority databases/registries
- Document review processes and ensure completion of day-to-day work within agreed SLAs
- Maintain data as per customer guidelines
- Collaborate with project quality roles to improve case quality
- Attend training sessions and develop skills continuously
- Coordinate with internal teams for necessary information
- Assist in training and mentoring new joiners as needed
