PV Assessment Lead and MSPR

CSL•King of Prussia, PA

1d•Hybrid

About The Position

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. You will be responsible for preparing adequate Pharmacovigilance assessments in the course of GMP deviation investigations, complaint investigations and other reports (e.g. BPDR, Monthly PV report to manufacturing site QA, PQR and APQR) on a high scientific level and in close cooperation with relevant stakeholders (e.g. Global Safety Lead, PTC team, QA managers). The position holder is responsible for the management and training of other functions that support the preparation of PV Assessments (external or internal) and acts as a subject matter expert during audits and inspections. Your main objective is the liaison between Global Regulatory Affairs & Safety - GRAS and the Product Quality Management functions at the CSLB manufacturing site Kankakee and Holly Springs. Together with the Global MSPR group, the position holder will also support Marburg, Bern, Broadmeadows, Tullamarine, Liverpool and St. Gallen sites. The role collaborates closely with the Global MSPR to ensure cooperation with Global Quality and the manufacturing sites QA. You will create and further develops the interface to the manufacturers QA. The Manufacturing Site PhV Representative supports GVP compliance for interactive procedures between QA and PhV. The role is highly visible on multiple management levels. The position holder is expected to adequately communicate actively and initiatively on a high scientific as well on a cultivated interpersonal level. The position holder will be further developed to act self-responsible and with high flexibility. The role will require travelling (US) in coordination with the Head of MSPR.

Requirements

University graduate (Diploma/MA/MS, PhD) in life-sciences, e.g. pharmacy or pharmacology or biology or human / veterinary medicine
Technical knowledge of the PV and quality relevant regulatory framework and good knowledge of international regulations and standards (such as GVP, GMP).

Responsibilities

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, DataRetrieval, 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.