The Manufacturing Site Pharmacovigilance Representative's main objective is the liaison between Global Clinical Safety and Pharmacovigilance and the Product Quality Management functions at the CSLB manufacturing sites in Marburg, Bern Kankakee and Broadmeadows.
The role collaborates closely with the Global MSPR to ensure cooperation with Global Quality and the manufacturing sites QA. The Manufacturing Site Pharmacovigilance Representative creates and further develops the interface to the manufacturers QA. The position reports to the Global MSPR. The position holder prepares adequate PhV assessments on a high scientific level and in close cooperation with relevant stakeholders (e.g. Clinical Safety Physician, PTC team members, Quality Managers). 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.
Main Responsibilities and Accountabilities:
•Liaison person between GCSP and the CSL Behring manufacturing site Quality Management Departments:
•Appropriate two-way communication in order to address potential safety relevant findings in a timely manner
•Represent GCSP in inspections and audits as Subject Matter Expert for Pharmacovigilance
•Provide timely Pharmacovigilance Assessments for safety relevant PTC, deviations, change control in accordance with global and local processes. · Prepare timely and appropriate responses to safety related requests from health authorities: o Closely liaise with stakeholders within GCSP such as DataRetrieval, Clinical Safety Physicians, Clinical Safety Scientists, Local Safety Officers and others. o In close coordination with the Global MSPR: Prepare Pharmacovigilance assessments with GCSP Risk Management, based on GMSQs risk assessments and preparation of Pharmacovigilance statements for specific tasks.
· Create and further develop a two-way communication on emerging safety relevant issues with relevant interfaces: o Member of the weekly Global Safety Review Team (GSRT) o Inform GCSP on safety relevant matters from the manufacturing site Quality organizations in support for the Global MSPR. o Together with the Global MSPR: Communicate safety relevant information from GCSP into the manufacturing sites QA organizations and actively participate in decision making.
•Support the nationally nominated / qualified person for PhV (Stufenplanbeauftragte/r Stellvertreter) for Germany:
•Maintenance of a PhV system that is compliant with German regulations and standards (system responsibility currently delegated to the EU-QPPV.
•Share the 24/7 availability for authority requests with the Global MSPR / Stufenplanbeauftragter.
•Responsibility for conduct of continuous PhV evaluation and regulatory reporting of ADR reports and other medical risk information received from the German market and /or identified in the local scientific literature in close cooperation with EU-QPPV and Case Management.
•Overview of the safety profiles and any emerging safety issues in relation to the CSL products authorized in Germany
•Participate in inspections and audits
University graduate (Diploma/MA/MS, PhD) in life-sciences, preferably in 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).
•Knowledge of local and also global CSL business processes and governance structures.
•Excellent written and verbal communication skills in English
•Knowledge of CSL product profiles.
•Strong relationship builder and communicator at various levels of the business.
•Sound and balanced judgment; able to assess and handle risks; self-confident, proactive and decisive.
•Able to work effectively and collaboratively across site functions and the GCSP organization.
•Strong organizational skills.
•High ethical standards as well as personal credibility, the ability to gain trust at the senior executive level.
•Willing to learn the principles of internal audits and authority inspections.
•Good team player and networker with excellent interpersonal and communication skills.