• Provide GVP consultancy and other pharmacovigilance regulatory expertise to support the organization in maintaining required compliance

• Independently lead the conduct of pre-inspections and mock inspections for all PV Health Authority inspections, GMP inspections which involve PV topics as well as 3rd party audits of PV system in the Region

• Lead the development and maintenance and execute the Global PVRQA Audit Program based on the long-term PV Audit Strategy in line with GVP Module IV (PVRQA audits of applicable global systems across GCSP, GRA, GMA and respective interfaces, affiliates and 3rd party vendors) in the Region

• Analyze audit observations, gaps and systematic issues to help to support continuous improvement within GCSP, GRA, GMA as well as affiliates, 3rd party vendors and other interfacing functions

• Together with the PVRQA Regional Head, ensure efficient PVRQA presence in the Region, including profound and efficient interfacing with stakeholder functions in relation to audit and inspection strategies as well as non-compliance trends

• Management of initial qualification of PV service providers in the Region, as well as other GxP service providers as they touch Pharmacovigilance. Ensure processes (including respective KPIs) are in place for a continuous quality oversight of all active service providers in the Region as well as maintenance of the respective qualified service provider list.

• Independently manage QA oversight of PV related BT systems (i.e. WAVES, Quosa, PV Central/PV Reports) as an integral part of BT QMS, as assigned.

• Support development, maintenance and continuous improvement of Global PVRQA (processes, tools, etc.). Stay abreast of current quality and compliance regulations, guidelines, methodologies and trends, and implement or propose improvement initiatives in response.

• Contribute ideas to the larger strategic vision of PVRQA and RD Quality and interact with the respective Leadership Teams to ensure continuous alignment on vision.

• Domestic and International Travel, as required (up to approximately 35%).

• Preferably, graduate degree in Scientific Discipline/ Life Sciences or related disciplines, or alternatively a bachelor’s degree and significant work experience as below.

• Minimum of 7 years of pharmaceutical industry or research/management experience, minimum 5 years’ experience in Pharmacovigilance Quality Assurance or other GxP Quality Assurance experience.

• Previous experience in managing or participating in regulatory inspections.

• Good knowledge of Pharmacovigilance / Good Clinical Practices regulations (GVP, CFR, GCP), quality systems (SOPs), CAPA programs, and audit procedures and reporting

• Experience of working in a Quality related and/or Process Management related environment /role

• Strategic development and analytical skills

• Experience in managing processes with a continuous improvement approach

• Strong leadership and communication skills with special emphasis on collaboration, influencing and negotiation skills

• Ability to think strategically and to quickly analyze complex circumstances and problems, and to drive appropriate decisions and actions

• Excellent communication and training skills, including English language skills