Senior Case Processing Oversight Manager

CSL Plasma; Maidenhead; On-site; GBP 70,000 - 90,000; Full time

Job summary

A leading biotherapeutics company is seeking an experienced professional to oversee case management and regulatory reporting requirements. The ideal candidate will have over 10 years of experience in Clinical Trials and Pharmacovigilance, alongside a strong knowledge of regulatory rules. This role offers a chance to contribute to the improvement of case management processes and ensure compliance within a dynamic team environment.

Benefits

Well-being support

Innovative work environment

Qualifications

• Minimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance experience.
• Proficient knowledge of global and local regulatory rules and regulations.
• Direct experience authoring/updating Standard Operating Procedures (SOPs) and work instructions.

Responsibilities

• Oversee follow-up activities in accordance with procedural documents.
• Serve as case processing Subject Matter Expert for procedural documents.
• Collaborate with stakeholders to optimize case management processes.
• Ensure audit and inspection readiness including CAPA management.

Skills

Clinical Trial experience

Post-marketing Pharmacovigilance experience

Knowledge of regulatory rules

Experience authoring/updating SOPs

Education

BS/BA, RN, Pharmacist or similar

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 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!