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Sumitomo Pharma Manager, Pharmacovigilance and Risk Management (PVRM) in Boston, Massachusetts

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 (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=3440496098&u=https%3A%2F%2Fwww.us.sumitomo-pharma.com%2F&a=https%3A%2F%2Fwww.us.sumitomo-pharma.com+) or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) .

Job Overview

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Director, Vendor Management.

The Manger reports to the Director of PV Quality and Compliance, Vendor Management and works independently with moderate supervision and effectively manages time and workload. The Manager supports oversight and management of the PVRM case processing vendor, including quality monitoring and liaising with the PVRM Director of Compliance to mitigate noncompliance risk for PV vendor, business partners, affiliates, and subsidiaries; maintains, and ensures compliance with the pharmacovigilance quality management system, including but not limited to policies, procedures, manuals, training, surveillance and key performance metrics. The Manager works closely with the Quality organization as a member of a cross-functional working team to support audit and inspection preparedness. Lastly, the Manager works closely with the Information Management (IM) and Safety Science groups as part of a matrix team to support Pharmacovigilance activities.

Job Duties and Responsibilities

  • Manages PVRM case processing vendor to the responsibilities outlined in the contract and statement of work, including vendor Key Performance Indicators, quality review oversight, reconciliation, vendor training, and deviation management support.

  • Supports the relationship with the business partners, affiliates, and subsidiaries to ensure consistent and quality performance by the case processing vendor.

  • 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.

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

  • Manages ad hoc PVRM or cross-functional projects as applicable.

  • Global safety planning and coordination member to support global initiatives.

  • Participates with senior management to establish strategic plans and objectives;

  • Monitors and trends Drug Safety and Pharmacovigilance performance indicators;

  • Contributes to key compliance reports for senior management;

  • 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;

  • Ensures functional lines prepare and maintain processes to support a quality pharmacovigilance system;

  • Contributes to standard operating procedures relevant to pharmacovigilance;

  • Contributes to the maintenance of the pharmacovigilance system master file;

  • Identify gaps in the pharmacovigilance system and implement solutions;

  • Assist with other Safety department activities as needed.

Key Core Competencies

  • Works 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 regulations

  • Ability to multi-task under limited direction and on own initiative

  • Good interpersonal, written and verbal communication skills

  • Proven 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 Experience

  • Bachelor's degree preferably in a scientific, regulatory, or health-related field.

  • Minimum 8– 10 years (w/o Bachelor’s) or 6 – 8 years (with Bachelor’s) of relevant experience in biotech or pharmaceutical industry

  • Minimum 5 - 6 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.

he 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 employer

Sumitomo 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 (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf)

EEO is the Law Poster Supplement

Pay Transparency (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

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 (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=3440496098&u=https%3A%2F%2Fwww.us.sumitomo-pharma.com%2F&a=https%3A%2F%2Fwww.us.sumitomo-pharma.com+) or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=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 Mission

To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide

Our Vision

For Longer and Healthier Lives, we unlock the future with cutting edge technology and ideas

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