Global Life Sciences Compliance Specialist
2 weeks ago
We are seeking a skilled Global Life Sciences Compliance Specialist to join our multinational team in Budapest. As a key member of our Pharmacovigilance department, you will play a critical role in ensuring compliance with regulatory requirements.
About the Role:- Receive and process information from various channels, including voice calls and emails, related to safety reports.
- Route safety reports to the appropriate departments, such as Medical Information and Quality Assurance, as necessary.
- Monitor mailboxes, triage patient safety reports, and maintain email records.
You will be responsible for maintaining accurate records, updating shared folders, and handling source documents. Your duties will also include entering data into our front-end system, obtaining consent from reporters, and assessing case validity.
Additionally, you will perform initial checks, search databases to prevent duplicate entries, and ensure upfront clarification requests for data discrepancies. You will enter safety information into the front-end system, evaluate case seriousness, and translate and back-translate safety information as required.
Your expertise will also be utilized to review and archive source data records, identify discrepancies, and maintain email clarifications. You will document reviews, extract data from Health Authority databases, and process Individual Case Safety Reports.
Key Requirements:- University or College degree in a Life Sciences, Pharmaceutical, or Medical field is essential.
- Proficiency in German (B2 level) and English is mandatory.
- Previous experience in a similar role or at a pharmaceutical company is highly advantageous.
- A competitive salary: €35,000 - €45,000 per annum.
- An annual bonus scheme.
- Risk and accident insurance.
- Cafeteria benefits.
- Fitness package.
- Home-office arrangement (4 days a week).
- Reimbursable language courses.
- A fast-paced, growing company culture.
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