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 Food and Drug Administration (FDA), MHRA, PEI, EMA, PMDA, World Health Organization, country and regional regulations for the reporting of 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 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.

• May support risk management operations, including signal detection and management, ongoing review of literature and compilation and interpretation of safety data to support product strategies

• Ensures correct coding of all event and drug terms.

• Ensures inter and intra-consistency for case evaluations.

• Participates in ICSR reporting compliance analysis and respective CAPA.

• Serves as mentor/trainer to Medical Evaluators and Case Managers.

• Together with Risk Management function, develops and maintains Medical Concepts to support internal decision making and safety analyses for safety surveillance; provides expertise to pharmacovigilance and clinical development programs with regards to safety data/ SAE coding.

• Manages regular MedDRA upgrades and provides impact analysis to RM physicians and ME.

Qualifications:

• 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 driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor  visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

 To learn more about inclusion and belonging visit https://www.csl.com/car