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 (+) or follow us on LinkedIn () .Job OverviewWe are currently seeking a dynamic, highly motivated, and experienced individual for the position of Manager, CTSA.

The CTSA 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 ResponsibilitiesManages 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 licensesPrimary 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 stakeholdersWorks closely with the CTSA Lead responsible for PVRM and non-PVRM vendor compliance management to address compliance issues originating with the vendorManages 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 regulationsManages 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 coordinatorWorks 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 auditsConducts 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 migrationManages 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 consistent and quality performance by the case processing vendor.

Works with the Quality organization for audit and inspection preparedness and supports PVRM during regulatory inspections and audits.

Global safety planning and coordination member to support global initiatives.Collaborates with Quality on corrective action and preventative actions relevant to pharmacovigilance including but not limited to documentation of quality review findings, root cause analysis, trend analysis, implementation of process improvement measures, and effectiveness checks;

Contributes to standard operating procedures relevant to pharmacovigilance;Assist with other Safety department activities as needed.

Key Core CompetenciesWorks effectively with minimal supervision.High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture.

Self-motivated with solid management skills, and the ability to lead or participate effectively in cross-functional teams.

Skilled mentoring and coaching to develop team deliverables.Proficient verbal and written communication skills.Proficient in MS Office applications and adaptable to technology and systems.

Knowledge of current US and international pharmacovigilance regulationsAbility to multi-task under limited direction and on own initiativeGood interpersonal, written and verbal communication skillsProven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment;

honesty, integrity, and trust building behaviors in all dealings is essential and required.Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction.

Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.

Education and ExperienceBachelor's degree preferably in a scientific, regulatory, or health-related field.Minimum 6 8 years (with Bachelor’s) of relevant experience in healthcare industryMinimum 3 years of experience specific to Pharmacovigilance operations and compliance.

Strong understanding of U.S. regulations and guidance, and a fundamental working knowledge of global regulations and guidance, e.

g., European Economic Area, United Kingdom, and Canadian regulatory frameworks.The base salary range for this role is $124,500 to $156,000.

Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.

Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter.

Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer : The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification.

They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.Confidential Data : All information (written, verbal, electronic, etc.

that an employee encounters is considered confidential.Compliance : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

Mental / Physical Requirements : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary.

Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employerSumitomo Pharma America (SMPA) is committed to a culturally diverse workforce.

• All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin;
• age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression;
• affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status;

atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

For more information about EEO and the Law, please visit the following pages : Equal Employment Opportunity is THE LAW ()EEO is the Law Poster SupplementPay Transparency ()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 (+) or follow us on LinkedIn () .At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company’s cultural pillars.

Our MissionTo broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwideOur VisionFor Longer and Healthier Lives, we unlock the future with cutting edge technology and ideas