Regional Pharmacovigilance Safety Officer (RSO) MEA Jobs in Dubai – UAE at CSL Behring
Title: Regional Pharmacovigilance Safety Officer (RSO) MEA
Company: CSL Behring
Location: Dubai – UAE
Type: Full Time
Position: Regional Pharmacovigilance Safety Officer (RSO) MEA (m/f/x)
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. 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 , 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 Do…