Specialist/ Senior Specialist, PhV Affiliate Governance and QPPV Office

Job content

Summary

The Senior Specialist, PhV Affiliate Governance and QPPV Office provides the support necessary to ensure the governance and oversight of the local pharmacovigilance (PhV) functions, PSMF maintenance and EU QPPV office activities are fulfilled. This oversight is also ensured during expansion of the portfolio and territories of the Company.

The Senior Specialist, PhV Affiliate Governance and QPPV Office has an important role in the tracking of quality, compliance and training needs for the local affiliate organizations and EU-QPPV. In addition, this position supports the Local Person for Pharmacovigilance (LPPV) vendor, business partner and Incyte oversight of this responsibility by maintaining, developing and improving tracking tools.

Duties And Responsibilities

• Support the governance and oversight of the local PhV functions by developing and improving local processes, tracking local activities and requirements, maintaining relevant documents, participating to the review of contracts and Pharmacovigilance Agreements, organising and/or participating to PhV meetings and alerting PhV Affiliate Governance management of significant local PhV functions process deficiencies.
• Ensure oversight of local PhV activities during the expansion of the portfolio and/or global footprint of the Company.
• Participate to PhV audits and inspections, assists with the preparation of CAPAs.
• Assist the PSMF Coordinator to ensure the maintenance of the Pharmacovigilance System Master File (PSMF)
• Participate in the development and review of global procedures to ensure processes are compliant with regional regulations and global standardization.
• Collaborate with the process owners within pharmacovigilance and other functions engaged in the PhV System (such as commercial, GVP-, GCP-, GMP quality, medical affairs) who support local PhV processes and works cross-functionally to maintain global standards for pharmacovigilance activities to ensure patient safety.
• Collaborate with and maintain effective working relationships with business partners and vendors to ensure PhV processes as mandated in approved existing agreements are adequately understood and followed.
• Provide training to relevant stakeholders, in scope of PSMF maintenance, governance of local PhV functions or other applicable topics.
• Support to EU QPPV office, e.g. notifications of change of EU QPPV, organisation and/or participation to EU QPPV – PhV management meetings, maintenance of xEVMPD.
• Pharmacovigilance activities at the Swiss Affiliate: assist the LPPV in Switzerland in the performance of activities including e.g. adverse event handling (e.g. receipt, tracking, follow-up, reconciliation, submission), development of local procedures, local literature search, participation to PhV audit and inspection, Safety Intelligence; be available as contact person for Swissmedic in the role of LPPV for Switzerland.
• Maintain files and systems as appropriate.
• Completion of additional tasks and project as assigned by management.
  

Requirements

• Bachelor’s degree in a science or healthcare related discipline, or equivalent.
• Minimum of 4 years pharmacovigilance experience (Specialist minimum of 2 years), including content and management of PSMF.
• Previous experience working in a QPPV Office preferred.
• Understanding of global pharmacovigilance regulations (e.g, GVP, ICH Guidelines) and pharmacovigilance system.
• Knowledge of xEVMPD database and guidance preferred.
• Experience collaborating with external partners to drive process and technical innovation.
• Experience in managing meetings and provide training.
• Interest in developing and reviewing procedural and/or legal documentation.
• Excellent computer skills (i.e. Microsoft Word, Excel, Outlook, and Power Point).
• Ability to work effectively within a team environment.
• Strong tracking, coordination and project planning skills.
• Solid organizational, time management, and problem-solving skills.
• Good verbal and written communication skills.
• Must be fluent in English and comfortable in a fast-paced, demanding work environment
• Maintains high ethical standards, including a commitment to Incyte values and behaviors
  

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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