Regional Pharmacovigilance Lead EMEA

• Responsible for establishing PV functions and providing guidance, support and ensuring compliance at the regional/country level
• Ensure visibility of PV compliance in the regions/countries through interaction with senior local/regional and global roles outside of the PV organisation and membership at Regional Lead team forums and governance boards
• Escalate non-compliance in the region to the Head of Pharmacovigilance (PV) Operations Consumer Health Safety, EU QPPV and Head of CH Safety as appropriate
• Accountable for implementation of new regulations in the region by liaising with central/regional teams and third parties
• Ensure appropriate resources and capabilities are available in the team to meet and execute essential PV requirements to ensure that quality standards are met across the area and that best practice is shared and implemented
• Work closely with the local/regional commercial and HR business partners in the selection, onboarding and training of EMEA PV team including local QPPVs/Local PV contacts
• Provide team leadership and ensure talent development and succession planning is in place for all key roles
• Drive risk-proportionate and fit for purpose approach for PV in the region whilst ensuring maximal operational efficiency and maintaining high standards of global PV compliance
• Understand the business model and risks in each country in the region and work closely with the commercial teams to ensure appropriate PV support is implemented
• Act as Deputy Consumer Healthcare Qualified Person for Pharmacovigilance (QPPV) for Europe
• Provide strategic direction for outsourced Local PVs
• Ensure consistency of process and flow of communication between all parties involved in managing the PV System including but not limited to other PV functions / Third parties / countries
• Work closely with the Head of PV Operations, the EU QPPV and other PV functional leaders to ensure alignment and consistent implementation of global processes, policies and procedures
• Point of contact and host for all inspections and audits in the region
  
  

• MSc Degree in a scientific or medically related field, and strong knowledge of Pharmacovigilance (high degree preferred)
• Extensive experience in Pharmaceutical industry and related discipline – Pharmacovigilance, Materiovigilance, Cosmetovigilance, Nutrivigilance
• Sound knowledge of regulatory guidelines and legislations in Europe, Middle East and Africa and of GVP guidelines, ICH, GCP. Experience in CAPA Management, audit and inspection
• Demonstrated leadership and managerial experience in the pharmaceutical industry in pharmacovigilance, clinical development, medical information or quality management
• Experience as a local QPPV would be an advantage
• Excellent written and verbal communication, including presentation skills, and the ability to effectively contribute, influence and liaise with senior leadership teams
• Ability to effectively organize and manage multiple company initiatives, build high-performing teams and develop talent
• Strong understanding of safety databases and other safety systems
• Strong background/understanding of quality assurance processes and activities
• Ability to prioritize and multi-task successfully in a fast-paced environment
• Ability to react constructively in a high-energy and fast-paced environment
• Ability to work autonomously, as well as act as a strong team player and leader in a matrix environment
• Excellent interpersonal, analytical, negotiation, decision making and problem-solving skills
• Ability to establish and maintain open relationships within the organization and with authorities
• Culturally aware and able to work externally with the various Country cultures, be aware of the local legal requirements and local rules and regulations
• Excellent English spoken and written