Regional Safety Officer (RSO) MEA (m/f/x) - 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!

We are currently looking to appoint a

Regional Safety Officer (RSO) Middle East and Africa (MEA) – located in Dubai

The Regional Safety (RSO) is:

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

The Regional Safety Officer (RSO) MEA is responsible for:  

• PV responsibilities for all CSLB products licensed, marketed or supplied within MEA.
• PV compliance with local as well as international regulations (e.g. GVP) and ensures inspection readiness.
• Maintain up-to-date information relevant for the Pharmacovigilance System Master File (PSMF).
• Responsible for implementing and maintaining PV related regulatory requirements defined in the applicable regulations within MEA and informing GCSP regarding new PV/safety relevant regulations.
• Develops and implements local PV procedural documentation (in accordance with GCSP policies and procedures and the local document management system).
• Acts as the Primary PV contact for the local Competent Regulatory Authority within MEA, collaborates with relevant interfaces (i.e. Regulatory Affairs) in regards to communication between CSLB and the local Competent Regulatory Authority.
• Responsible for Individual Case Safety Reports (ICSRs) handling (receipt, translation, timely reporting, tracking, follow-up, document archiving, and reconciliation).
• Responsible for timely and accurate submission of aggregate safety reports (as required).
• Manages the PV training requirements of affiliate personnel and personnel of Affiliate 3rd Parties
• Ensuring these personnel are aware of their PV reporting obligations and processes.
• Ensure that a local business continuity plan exists so that ICSR handling can continue during a crisis.
• Provides a local interface between global GCSP organization and all local functions such as local Regulatory Affairs, and the Regional General Manager to ensure timely implementation of Risk Minimization Measures in the territory.
• Develops the Regional PVAs in close cooperation with the GCSP PV Agreements team
• Selection of local PV Vendors.
• Supports internal and external PV audits and inspections within MEA

Qualifications and Experience Requirements:

• Bachelor degree or equivalent, Medical Documentation, Master’s, PhD, or equivalent in a life science discipline
• 5+ years Pharmacovigilance experience in multinational pharmaceutical industry
• 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

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

Apply Here