Spanish speaking Affiliate Pharmacovigilance Associate
3 days ago
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Employment Type:
Full-time
Location:
Budapest
Shift Pattern:
General
Work From Office (WFO):
We currently work from the office 2 days per month. This arrangement is flexible and may change to 1–2 days per week based on HR communication.
We Offer
- Competitive salary and benefit package (cafeteria + annual bonus)
- Training and continuous learning and certification opportunities
- Free medical benefit package
- Reimbursable language courses
- Risk and accident insurance
- Chance to be part of a rapidly expanding organization
- Multilingual, multicultural environment with native colleagues
- All You Can Move SportPass (at a discounted price)
- Team events, company events
- Relocation package
- High value awards and recognitions
Your Profile
- Graduate in Pharmacy or Life Science
- 1 year of Pharmacovigilance or relevant clinical experience
- Min. B2 spoken and written Spanish and English proficiency
Key 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.
- Anonymize/redact source documents and/or AE forms (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.
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