CSL Behring – the global biotherapies provider driven by its promise to save lives and to improve the quality of life for people with rare and serious medical conditions.
For Intercontinental Commercial Operations Organization located in Bern we are looking for a:
Regional Safety Officer (ECI region)
Your main tasks:
Handling of Individual Case Safety Reports (receipt, tracking and follow-ups) from all sources from the region. Track and monitor submission of ICSR and PSURs to the local HAs. Notification and escalation of emerging or critical safety issues involving CSL products occurring in the region.
Preparing, maintaining and keeping oversight of Pharmacovigilance (PV) agreements to ensure a seamless flow of PV critical information from and to local regulatory agents, distributor/3rd party service providers and CSL. Responsible for PV Vendor selection and management (if required).
Providing PV training of Commercial Operations Intercontinental ECI Region personnel and business partners ensuring that all CSL employees or partners are aware of their PV reporting obligations. This includes the development of training materials, the delivery of regular and ad-hoc training, and the monitoring of training compliance.
Participates in PV audits, assisting in all audit preparation activities (internal and external 3rd parties) and informing all relevant functions about up-coming PV or Quality related audits/inspections. Involved in the development of a CAPA plan and the close or and any audit action items.
Develops and implement PV and Quality procedural documentation (in accordance with CSL policies and procedures).
Liaising between the Medical Affairs and GCSP regarding named patient programs, post-authorization studies or any other activities/initiative run by Medical Affairs/Commercial Operations that may involve handling/receipt of any safety information.
Ensures, with Medical Affairs that all medical information enquiries received are screened, and when the enquiry meets the criteria for an ICSR, is appropriately handled in accordance with the company procedures.
Physician (M.D), Pharmacist or MA/MS, PhD in life science
Professional experience in pharmacovigilance or regulatory affairs in a multinational innovative pharmaceutical company.
Understanding Quality systems and processes
Extensive project management experience
Languages: Fluency in English and German or French. Knowledge of Slavic languages or Arabic would be an asset.
We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.
CSL Behring is committed to provide equal employment opportunity for all.
CSL Behring AG
Mr Patrick Plüss
Talent Acquisition Consultant