Regional Qualified Person for Pharmacovigilance (QPPV) & Quality Manager, Dubai

We are currently looking for a Regional Qualified Person for Pharmacovigilance (QPPV) & Quality Manager to join our growing GCC affiliate (Gulf Cooperation Council). Reporting directly to the Medical Director GCC with a dotted line to the International QPPV and Global Quality Manager, you will be responsible for the local (Vifor Pharma affiliate UAE) and regional PV activities in close collaboration with commercial partners ensuring that Vifor Pharma maintains its license to operate through compliance with all GVP rules and regulations for the products marketed. Additionally, you will be responsible to ensure the implementation and maintenance of robust compliance tracking, monitoring, evaluation and escalation processes with respect to the PV system and its PV related Quality Management System. For this you will provide senior management and stakeholders with compliance oversight thus ensuring patient safety and inspection readiness. Furthermore, your tasks and responsibilities will include, but are not limited to, the following:

PV responsibilities:

• Maintaining the Vifor PV system as per local / regional legislation as well as, as much as possible in line with the global pharmacovigilance system
• Having PV system oversight in the region i.e. PV activities executed by commercial partners by collecting metrics and monitoring KPIs
• Monitoring the safety profile (Benefit / risk balance) of Vifor products in the territory under his/her responsibility.
• The local /regional QPPV will be legally responsible for PV activities in the country /region and will act as first point of PV contact with Health Authorities
• The RQPPV shall have sufficient authority to influence the set-up and performance of the quality system as well as pharmacovigilance activities and to promote, maintain and improve compliance with the legal requirements without the necessary accountability for the execution of the various activitie.
• Is assigned Local Drug Safety Responsible for Vifor Pharma, UAE
  

Quality responsibilities:

• Acting as quality business partner for all Quality-related topics aligning with the global Quality team on the partners in the region
• Preparing and maintaining the quality management system in place for the region.
• Ensuring quality oversight and maintain status control on local GxP service providers in compliance with supplier management SOPs
• Providing GxP training to employees on GCC Local Quality Procedures and global processes according to training plans and the quality management system in place
• Responsible for reporting product complaints and deviations occurring in the Region
• Executing change management, CAPA (implementation and Risk Management within quality function).
  

The new Regional QPPV & Quality Manager for our GCC region will bring the following qualifications and expereince:

• Pharmacist or Master Degree Biology
• In–depth, demonstrated experience in most areas pertaining to Pharmacovigilance, and Pharmacovigilance Legislation; at least 3 year work experience in PV functions
• Ability to accurately and effectively evaluate, interpret and present data contained in medical / scientific literature as well as relevant for study design and conduct
• Understanding of medical aspects in therapeutic areas relevant for Vifor Pharma, along with willingness to develop in-depth expertise
• Relevant experience in quality function at least 2 years work experience.
• Professional level in Arabic and English, both in oral and written communications.
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