Medical Evaluator SeniorГерманияR-1317901010 CSL Behring GmbH (DE)
The Application Change Management Senior Manager is responsible for implementing and ensuring compliance to the established Computerized System Change Management governance. This role is responsible for the Application Change Advisory Board (CAB) and works directly with the CSL Group managed service partner and application teams to gather, analyze, gain approval for, and schedule changes. This role is also responsible for the continuous improvement of the Application Change Management process.
- Manage and direct functions to comply with standard operating procedures, regulatory safety and pharmacovigilance in compliance with national and international regulations, such as relevant GxP guidelines and national and international legislations and regulations as well as aggregate safety reports in area of responsibility
- Develop and implement pharmacovigilance procedures and process across the company and ensures the uniform and timely processing of regulatory requirements.
- Implement relevant KPIs/KQIs track and trend analysis and initiate corrective and preventative action when required.
- Contribute to regulatory required documents such as the PSMF, in line with international regulations, guidelines and internal standards.
- Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory requirements and keep compliance as well as quality.
Your skills and experience
- May drive cross functional BT projects to support the business and to improve inspection readiness.
- Develop and prepare reports for company management as well as external regulatory agencies.
- May provide medical evaluation of adverse event reports.
- Assist in the preparation of new drug application safety updates, investigational new drug safety reports, investigator communications, product labeling/package inserts and other reports as necessary.
- May work with data management in the ongoing development and maintenance of databases.
- Accountable for timely and accurate analysis of safety data, signal detection and management.
- Bachelor degree, Medical Documentation, or equivalent in a life science discipline or Masters (or international equivalent) in science, medicine/health sciences, or epidemiology; or; Bachelor degree (or international equivalent) in science, medicine/health sciences, or epidemiology with an increased experience requirement of an additional 3 years industry experience in a related role
- 8-10 years Pharmacovigilance experience in multinational pharmaceutical industry
- Expert knowledge of local/international regulations and PV processes
- Experience with regulatory inspections• Experience in administration of complex data sets
- Experience in project-managing CAPA and SOP development
- Experience in GxP
- Experience with relevant software applications
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About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
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