Case Processing Oversight Manager

Responsibilities

• Ensures compliance with standard operating procedures, regulatory safety and pharmacovigilance in compliance with national and international regulations, such as the FDA, MHRA, PEI, EMA, PMDA, WHO, and country/ regional regulations for reporting adverse events to regulatory agencies.
• Develops and implements pharmacovigilance guidelines and ensures the uniform and timely processing of adverse event data on all marketed products in development.
• Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
• Develops and prepares reports for company management as well as external regulatory agencies.
• May provide medical evaluation of adverse event reports.
• Assists in the preparation of safety updates for new drug applications, 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.
• May support risk management operations, including signal detection and management, ongoing literature review, and compilation/ interpretation of safety data to support product strategies.
• Ensures correct coding of all event and drug terms and consistency for case evaluations.
• Participates in ICSR reporting compliance analysis and CAPA.
• Serves as mentor/trainer to Medical Evaluators and Case Managers.
• Collaborates with Risk Management to develop and maintain Medical Concepts to support internal decision making and safety analyses for safety surveillance; provides expertise to PV and clinical development programs regarding safety data/SAE coding.
• Manages regular MedDRA upgrades and provides impact analysis to RM physicians and Medical Evaluators.

• Bachelor degree or equivalent, Medical Documentation, Master’s, PhD, or equivalent in a life science discipline
• 5+ 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 with relevant software applications

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

About CSL Behring

CSL Behring is a global biotherapeutics leader focused on serving patients’ needs by using the latest technologies. We discover, develop and deliver innovative therapies for conditions in immunology, hematology, cardiovascular/metabolic, respiratory, and transplant areas. We operate a large plasma collection network and have a global presence.

Equal Opportunity

Employer:

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit the CSL accessibility page.