Associate Manager, Compliance, Training & Strategic Alliance (CTSA), PVRM

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

Job Overview

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Manager, CTSA.

The CTSA Associate Manager is responsible for the management of the Pharmacovigilance (PVRM) and non-PVRM vendor(s) (e.g. Commercial) and will be responsible for adverse event handling and reporting and for general PVRM operations, including support of the global PV system. This role is responsible for training management, including development and maintenance of PV staff learning plans, assisting with compliance activities, quality monitoring, management of the CTSA mailbox, and is the PVRM Team Room administrator, including file management, archiving activities, and document retention initiatives. Additionally, the Manager contributes to audit and inspection preparedness, and is a member of a cross-functional working team supporting PVRM audits and inspections. The Manager works closely with the Information Management (IM) and Safety Science groups as part of a matrix team to support PV activities.

Job Duties and Responsibilities

• Support the PV operations Manager with PV operations deliverables
• With support from PV operations manager, manages PVRM vendors to the responsibilities outlined in the contract and statement of work. Develops a strategic relationship with the vendor and understands the vendor's business to ensure consistent and quality vendor performance. This also includes liaising with other SMPA departments to ensure non-PVRM vendors are meeting their AE training and reporting requirements. Manages a subset of scope of the vendor responsible for rest of world reporting to investigational licenses
• Primary liaison to non PVRM groups responsible for organized data collection schemes to ensure the collection and reconciliation of safety information generated from these activities. Manage PVRM reconciliation with internal and external stakeholders
• In association with PV operations manager, works closely with the CTSA Lead responsible for PVRM and non-PVRM vendor compliance management to address compliance issues originating with the vendor
• Manages the annual review and release of companywide Adverse Event (AE) policy training, ensuring that all training materials are compliant with corporate policies, SOPs, and local/global regulations
• Manages PVRM document storage ensuring all pertinent documents are processed and filed in accordance with SMPA SOPs. Manage archiving activities, including interactions with archiving vendors as applicable. Serves as records Information Management coordinator
• Works with the PV person(s) for compliance to address compliance issues and significant quality issues originating with the case processing vendor and License Partner.
• Participates in audit and inspection preparation as part of a cross-functional working team supporting regulatory inspections and internal audits
• Conducts routine AE case quality checks and supports the IM team with ad-hoc projects such as QC of test cases for special projects or during database upgrades or migration
• Manages other PVRM or cross-functional ad-hoc projects or assignments that require compliance, training & strategic alliance input, supporting desired high-performance "Safety First" culture in line with SMPA’s values and reinforcing related behaviors.
• Supports the relationship with the business partners, affiliates, and subsidiaries to ensure consi