Local Safety Officer - Saudi Arabia (m/f/x) - SaudiArabia

Location: Saudi Arabia
Company Name: CSL Behring

With operations in 35+ nations and ~ 20,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Responsibilities

Qualifications

We are currently looking to appoint a

Local Safety Officer (LSO) (m/f/x) Saudi Arabia – located in Saudi Arabia

The Local Safety (LSO) is:

• Responsible for Pharmacovigilance in the country of responsibility and fulfils local PV regulations and obligations in line with international requirements and CSLB processes under the guidance of GCSP Regions .

The key responsibilities of the Safety Officer in the Territory involve the establishment and maintenance of the local PV system , which includes (but is not limited to):

• PV responsibility for all CSLB products licensed, marketed or supplied within Territory of responsibility.
• PV compliance with local as well as international regulations (e.g. GVP) and inspection readiness.
• Maintain up-to-date information relevant for the Pharmacovigilance System Master File (PSMF).
• Develops and implements local PV procedural documentation (in accordance with GCSP policies and procedures and the local document management system).
• PV training for affiliate/Commercial Operations organization personnel as well as business partners in the territory.
• He/she acts as the Primary PV contact for the local Competent Regulatory Authority in the Territory, collaborates with relevant interfaces (i.e. Regulatory Affairs) in regards to communication between CSLB and the local Competent Regulatory Authority, facilitates communication from GCSP to the local Competent Regulatory Authority, ensures the communication of PV/safety related enquiries/ regulatory actions and requests from Competent Regulatory Authorities are forwarded to GCSP as required.
• Responsible for implementing and maintaining PV related regulatory requirements defined in the applicable regulations of the Territory and informing GCSP regarding new PV/safety relevant regulations in the Territory.

• Responsible for Individual Case Safety Reports (ICSRs) handling (receipt, translation, timely reporting, tracking, follow-up, document archiving, and reconciliation).

  This includes ICSRs identified from the local literature and from local Health Authorities.

Qualifications and Experience Requirements:

• Bachelor degree, Medical Documentation, Master’s, PhD or equivalent in a life science discipline
• 5+ years PV and/or Regulatory experience in the Pharmaceutical or Biotechnology industry
• Expert knowledge of the PV relevant regulatory framework in the Territory, and sound knowledge of international PV relevant regulations and standards
• Expert knowledge of local/international regulations and PV processes
• Experience with regulatory inspections
• Experience in administration of complex data sets
• Experience in project-managing CAPA and SOP development
• Experience with relevant software applications
• Fluency in English

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.

#Behring

Capabilities

Worker Type:

Employee

Worker Sub Type:

Regular