Manager, Pharmacovigilance Vendor Management - United States
- 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.
Vendor Qualification, Management, Compliance and Metrics, CAPAs, Escalation, Audits and Inspections, Processes (SOPs), Vendor Training, Contract Management
- 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 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