Up állások I. kerületben (egészségügy, gyógyszeripar)

• 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.

• Manage regulatory submissions and site start-up activities for clinical trials in Germany
• Prepare and review site regulatory documentation, ensuring completeness and compliance
• Negotiate site contracts and budgets with clinical trial sites

• Receipt / Download / Accepting of cases from Document Exchange Tool or electronically (or any other source)
• Translation of all relevant European Non-English information from source documents to English (if required) and updating relevant fields in Standard Adverse Event (AE) form

• Receipt / Download / Accept cases from Document Exchange Tool or electronically (or any other source)
• Translation of all relevant European Non-English information from source documents to English (if required) and updating relevant fields in Standard Adverse Event (AE) form

• Responsible for evaluating clinical data for Medicontur's medical devices, developing and updating documentation of clinical evaluation and post-market clinical follow-up, and
• Scientific and regulatory content writing

• Ownership: You will lead the implementation and continuous improvement of the local QMS, ensuring all SOPs and quality records are up-to-date and effective.
• Compliance: Act as the local expert for GDP and GMP requirements, safeguarding product integrity across the entire commercial affiliate.

Monitors CSR’s performance on a daily basis, by taping, listening to, reviewing and evaluating calls...