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Manager, Pharmacovigilance Vendor Management Wilmington United States,  


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 Incyte 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 Incyte 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 Incyte 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 Liase 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 Incyte 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 Incyte values and behaviors

Locations

Wilmington DE

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