Job Description
The position is part of a team responsible for continuous analysis of global documents and regulatory intelligence from interface functions to decide on relevant updates to regulatory and business reporting requirements.
Key Responsibilities
Oversee follow-up activities to ensure that follow-up of cases is done in accordance with the procedural documents
Oversee the assessment and the handling of literature articles identified by the Global Literature Office and local literature articles identified by the Safety Officers
Serve as case processing Subject Matter Expert (SME) for the input into procedural documents for case processing-related processes (e.g. SOPs, GDLs, work instructions); SME for incorporating process changes into the training material for case processing and for reviewing it for accuracy.
Collaborate with GSPV and external stakeholders to improve/ optimize case management processes including the development of SOPs and WIs in collaboration with other functions.
Maintain the tracking tool where new process decisions are tracked and ensuring that users are informed.
Supporting the investigation / assessment of ICSR compliance activities where required
Reg Intelligence (RING) assessment to decide on relevant updates or the impact on case processing due to regulatory updates.
Audit and inspection readiness including corrective & preventive action (CAPA) management.
SME for the initiatives or projects in the context of case processing
Skills and Experience Required
Minimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience.
Global pharmacovigilance database knowledge is required along with proficient knowledge of global and local regulatory rules and regulations.
Direct experience authoring/ updating SOPs, work instructions
Qualifications and Educations Required
BS/BA, RN, Pharmacist, or similar.
Our Benefits
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
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.
We want CSL to reflect the world around us
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. Learn more Inclusion and Belonging | CSL
Do work that matters at CSL Behring!
The position is part of a team responsible for continuous analysis of global documents and regulatory intelligence from interface functions to decide on relevant updates to regulatory and business reporting requirements.
Key Responsibilities
Oversee follow-up activities to ensure that follow-up of cases is done in accordance with the procedural documents
Oversee the assessment and the handling of literature articles identified by the Global Literature Office and local literature articles identified by the Safety Officers
Serve as case processing Subject Matter Expert (SME) for the input into procedural documents for case processing-related processes (e.g. SOPs, GDLs, work instructions); SME for incorporating process changes into the training material for case processing and for reviewing it for accuracy.
Collaborate with GSPV and external stakeholders to improve/ optimize case management processes including the development of SOPs and WIs in collaboration with other functions.
Maintain the tracking tool where new process decisions are tracked and ensuring that users are informed.
Supporting the investigation / assessment of ICSR compliance activities where required
Reg Intelligence (RING) assessment to decide on relevant updates or the impact on case processing due to regulatory updates.
Audit and inspection readiness including corrective & preventive action (CAPA) management.
SME for the initiatives or projects in the context of case processing
Skills and Experience Required
Minimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience.
Global pharmacovigilance database knowledge is required along with proficient knowledge of global and local regulatory rules and regulations.
Direct experience authoring/ updating SOPs, work instructions
Qualifications and Educations Required
BS/BA, RN, Pharmacist, or similar.
Our Benefits
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
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.
We want CSL to reflect the world around us
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. Learn more Inclusion and Belonging | CSL
Do work that matters at CSL Behring!
About CSL
For over a century, we’ve been an unstoppable force, from developing medicines that save and improve lives to vaccines that protect them. Today, with the combined expertise of CSL Behring (with oversight to CSL Plasma), CSL Seqirus, and CSL Vifor—and our singular commitment to relentlessly innovate—CSL’s offerings are more diverse than ever to help ensure patients and people everywhere get the treatments they deserve. We’re always improving so life can, too.
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