PV Assessment Lead and MSPR

Position Overview

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project‑led structure and a focus on collaboration, we’re building a future‑ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.

Could you be our next PV Assessment Lead and MSPR? The job is in our King of Prussia, PA Office. This is a hybrid position and is onsite three days a week. You will report to the Head of MSPR. The role will require travelling (US) in coordination with the Head of MSPR.

Responsible for preparing adequate Pharmacovigilance assessments in the course of GMP deviation investigations, complaint investigations and other reports as needed, on a high scientific level and in close cooperation with relevant stakeholders (e.g. Quality Managers) and with other contributors and experts (e.g. Global Safety Leads, MSPRs, PTC team members, LQPPV).

Responsible for managing and training of other scientists, stakeholders within GRAS and service providers on the PV Assessment processes and concepts incl. reconciliation.

Liaison person between GRAS and the manufacturing sites Quality Management Departments.

• Appropriate two‑way communication in order to address potential safety relevant findings in a timely manner.
• Membership as deputy of the Head of MSPR in the manufacturing site QA committees and the product review / recall teams.
• Represent GRAS in the Quality Management Review meetings (QMR) at the Kankakee and the Holly Springs sites.
• Represent GRAS in inspections and audits as Subject Matter Expert for Pharmacovigilance, esp. with physical presence at the Kankakee and Holly Spring sites.
• Provide timely Pharmacovigilance Assessments for GMP deviations, safety relevant PTC in accordance with global and local processes.

Prepare timely and appropriate responses to safety related requests from health authorities:

• Closely liaise with stakeholders within GRAS such as QPPVs, Data Retrieval, Global Safety Leads, Clinical Safety Scientists, Local Safety Officers and others.
• In close coordination with the Head of MSPR and the Formulation Safety Leads:
  Prepare Pharmacovigilance assessments under consideration of identified Medical Risks (Medical Risk Assessment - MRA) and prepare Pharmacovigilance statements for specific tasks / issues.

Create and further develop a two‑way communication on emerging safety relevant issues with relevant interfaces:

• Support the head of MSPR as a member of the Global Safety Committee (GSC)
• Inform GRAS on safety relevant matters from the manufacturing site Quality organizations in support for the MSPR team.
• Together with the MSPR team:
  Communicate safety relevant information from GRAS into the manufacturing sites QA organizations and actively participate in decision making.

Education:

University graduate (Diploma/MA/MS, PhD) in life‑sciences, e.g. pharmacy or pharmacology or biology or human / veterinary medicine

Experiences:
Technical knowledge of the PV and quality relevant regulatory framework and good knowledge of international regulations and standards (such as GVP, GMP).

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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…