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Manager, Pharmacovigilance Vendor Management Wilmington United States,  

Incyte (company)

Posted on : 23 May 2017

Project Description

  • Under the leadership of the Senior Director, Pharmacovigilance (PhV) Quality, Compliance & Safety Systems, this position provides oversight of pharmacovigilance vendor activities to ensure execution of global pharmacovigilance strategy though adherence to company global process, standards, and quality systems. 
  • Fosters a culture of continuous process improvement and identifies opportunities to further enhance quality and compliance of vendor engagements.  
  • Assists with implementation of compliance relevant activities with PhV vendors and review/implementation of Pharmacovigilance contracts as required. Participates in the audit and inspection process, including CAPA development/management.

Key activities: 
Vendor Qualification, Management, Compliance and Metrics, CAPAs, Escalation, Audits and Inspections, Processes (SOPs), Vendor Training, Contract Management

Job Responsibilities
  • Oversee and monitor the pharmacovigilance vendor related procedures which include qualification, management, escalation, and reporting of quality and compliance related issues. 
  • Ensures all applicable deliverables and necessary documentation are created, retained, and archived per company procedural, contractual, and applicable regulatory requirements 
  • Expert knowledge and understanding of the business priorities and requirements as it relates to pharmacovigilance processes and systems and is knowledgeable in developing the criteria for vendor oversight strategy 
  • In collaboration with the pharmacovigilance operations teams, develop relationships with vendors to foster mutual understanding of expectations, deliverables, and issue resolution 
  • Provide input for current and future contracted services as a part of the overall company vendor management strategy 
  • Develop and manage vendor governance with defined roles and responsibilities, communication pathway, and deliverables 
  • Lead and facilitate vendor oversight team meetings which include internal and external stakeholders with appropriate representation from various departments 
  • Liaise with operational representatives to resolve and mitigate vendor performance issues. 
  • Perform lesson?s learned as part of the continuous process improvement activities 
  • Lead and collaborate with internal and external stakeholders to identify and develop key performance indicators (KPIs) and key quality indicators (KQIs) as a part of company vendor management metrics. 
  • Perform periodic evaluation of KPI and KQI metrics to assess trends related to quality and compliance of vendor?s contracted deliverables and quality issues. 
  • Develop dashboard to help monitor vendor performance. 
  • Stay current with new or revised regulations, regulatory intelligence, and best practices 
  • Lead creation of SOPs and WIs for pharmacovigilance 
  • Provide audit and inspection support including lead inspection readiness program as appropriate 
  • Lead special projects and assignment as required. 

Minimum Requirements:
  • Minimum Bachelor?s degree in a healthcare or scientific-related discipline 
  • Minimum of 5 to 7 years of direct drug safety and pharmacovigilance experience including minimum of 3-4 years management and / or project management experience 
  • Good understanding of vendors/CROs management process required 
  • In depth pharmacovigilance knowledge, meeting facilitation and documentation skills required 
  • Experience in audit management and CAPA writing processes and experience in process design, development, management and SOP writing 
  • Understanding of Quality Management processes and compliance monitoring required 
  • Strong understanding of drug safety processes, FDA and other national or international regulations, and ICH guidelines required 
  • Exercises independent judgment and identifies and implements methods, techniques, and evaluation of criteria to achieve results 
  • Demonstrates strong analytical/problem-solving skills, and develops technical and/or business solutions to complex problems 
  • Effective communication (verbal and written) 
  • Strong negotiation and interpersonal skills, team player 
  • Excellent organizational skills with attention to details, advanced computer skills 
  • Ability to work independently with tight timelines and competing priorities 
  • Collaborate with senior staff in PhV to achieve the objectives of the Department. 
  • Possesses strong computer skills in drug safety applications, Microsoft Office Suite (Word, Excel, and PowerPoint) 
  • Must be fluent in English and comfortable in a fast-paced, demanding work environment 
  • Maintains high ethical standards, including a commitment to company values and behaviors


Wilmington DE

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