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Position Description Summary:

The Senior Case Processing Oversight Manager is responsible for overseeing all areas of single case processing in the global pharmacovigilance database from all sources. This includes ensuring that the vendor performs case processing in accordance with regulatory guidelines, PV agreements, and the Company's SOPs, as well as responding to specific questions or queries about cases.

The incumbent is also responsible for developing standards and processes, with a focus on global compliance, data quality and process optimization. This role ensures the efficiency of GSPV processes, not only within CM but across all PV and key interface functions. The aim is to optimize processes where possible and achieve efficiency and quality gains across R&D without compromising compliance.

Main 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.

Qualifications and Experience Requirements:

+ BS/BA, RN, Pharmacist, or similar.

+ 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

Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site (https://www.cslbenefits.com/csl/candidates) to see what’s available to you as a CSL employee.

About CSL Behring

CSL Behring (http://cslbehring.com/) 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 (http://www.cslplasma.com) . Our parent company, CSL (https://www.csl.com/) , 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 (https://www.csl.com/careers/inclusion-and-belonging) .

Do work that matters at CSL Behring!

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CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement