Sr Manager, Case Processing Vendor Oversight
Aimmune Therapeutics
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Posted on Friday, April 8, 2022
Position: Sr Manager, Case Processing Vendor Oversight
Reports to: Senior Director, Operations & Infrastructure, PPSRM
Location: Brisbane, California (can be remote based)
Summary
Responsible for development and maintenance of case processing excellence in Pharma Patient Safety & Risk Management (PPSRM), the Case Processing Vendor Oversight (CPVO) Lead reports to Senior Director Operations and Infrastructure PPSRM and contributes to the development, implementation, and successful oversight of the PV vendors to ensure quality delivery that meets global regulations.
Responsibilities:
Responsible for development and maintenance of case processing excellence in Pharma Patient Safety & Risk Management (PPSRM), the Case Processing Vendor Oversight (CPVO) Lead reports to Senior Director Operations and Infrastructure PPSRM and contributes to the development, implementation, and successful oversight of the PV vendors to ensure quality delivery that meets global regulations.
Responsibilities:
- Responsible for developing strategies, procedures, and program management for defined outsourcing activities for PPSRM. Ensures the quality, compliance, and cost- effectiveness of work delivered under multiple business process outsourcing contracts for critical safety services within PPSRM – Case processing (Clinical and Post Marketing) including follow up, Literature Surveillance, Reconciliation, Aggregate Reporting to assure global consistency. This may include other outsourced activities as identified.
- Manages a significant portion the PPSRM budget.
- Leads and establishes contract parameters, collects key metric information, and identifies/implements continuous improvement initiatives with the vendor(s), and responsible for overall vendor performance and ensuring service outputs are delivered on budget. Contributes to the development of the future case processing and outsourcing model(s) to achieve cost-effectiveness of contracted work.
- Responsible for regulatory compliance and inspection readiness of outsourced PV activities.
- Works extensively with the PPSRM Leadership Team (LT), as well as cross functionally and with vendor personnel, and ensures that vendor(s) align(s) with PPSRM vision, and their outputs directly support the ongoing assurance of the safety profile of Aimmune products.
Strategy Development and Execution:
Contributes to development and implementation of 1–3-year PPSRM Vendor Management specific objectives and plans as part of the overall PPSRM process strategy and operational plans. Participates as an Ad Hoc member of the PPSRM LT in the successful execution of PPSRM process vision, mission, objectives, and plans. Contributes to the development and successful implementation of annual PPSRM strategic goals and objectives.
Qualifications / Requirements Required:
- Minimum BA/BS, preferably with an advanced professional degree
- Minimum of 7 years relevant experience in the pharmacovigilance or combined PV/RA/QA, and/or clinical development, including extensive leadership experience.
- Planning, forecasting, and budgeting skills and experience
- 3-5 years of experience working with CROs, vendors, and relationship management
- Experience negotiating and managing outsource contracts for complete business processes
- Demonstrated effectiveness in external partner relationship management
- Planning, forecasting, budgeting, and monitoring skills and experience
- In-depth understanding of safety regulations for both marketed and investigational products, and excellent knowledge of global health authority requirements including ICH, CFR 21, FDAAA, EU GVP module
- Proven experience with establishing and maintaining (GxP) Quality Management Systems.
- Experience in planning, allocating and managing multiple projects in a heavily matrixed and/or cross-functional environment; demonstrated ability to effectively manage departmental budgets
- Proven experience in quality and process improvement activities
About Aimmune Therapeutics, Inc.
Aimmune Therapeutics, Inc., a Nestlé Health Science Company, is a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies and food digestion & absorption. Aimmune has one FDA-approved medicine for peanut allergy and other investigational therapies in development to treat other food allergies. In the area of food digestion and absorption, we offer treatments for Exocrine Pancreatic Insufficiency (EPI), a disorder where the pancreas does not make enough enzymes due to cystic fibrosis or other conditions. For more information, please visit www.aimmune.com.
Aimmune is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
This job is no longer accepting applications
See open jobs at Aimmune Therapeutics.See open jobs similar to "Sr Manager, Case Processing Vendor Oversight" Foresite Capital LP.