Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, 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.
The Senior Manager is a strategic leader responsible for overseeing Pharmacovigilance (PVRM) and non-PVRM vendor management, adverse event handling and reporting, and supporting global PV systems. This role oversees compliance training, quality monitoring, audit and inspection preparedness, and cross-functional initiatives to ensure operational excellence and regulatory adherence. The Senior Manager works closely with the PVRM Information Management (IM) and Safety Science groups and is a member of a cross-functional working team as part of a matrix team supporting PV activities.
Job Duties and Responsibilities
1. Lead strategic relationships with PVRM and non-PVRM vendors, ensuring contract compliance, quality performance, and alignment with business objectives.
2. Provide strategic oversight of adverse event (AE) management and reporting processes, ensuring compliance with global regulatory requirements.
3. Conduct routine AE case quality checks, support special projects, and collaborate within PVRM and Quality on root cause analysis, corrective and preventive actions, effectiveness checks, and process improvements.
4. Lead audit and inspection preparedness, participate in cross-functional teams, and support regulatory inspections and internal audits.
5. Develop and maintain PV staff learning plans, manage compliance activities, and serve as the primary liaison for organized data collection and reconciliation of safety information.
6. Oversee the development, maintenance, and continuous improvement of standard operating procedures (SOPs) across PV operations and quality systems to ensure consistency, regulatory compliance, and operational excellence.
7. Support global safety planning and coordination, and maintain relationships with business partners, affiliates, and subsidiaries.
8. Provide expert support for Pharmacovigilance Agreements (PVAs), including but not limited to drafting, reviewing, and maintaining PVAs with internal and external partners. Support Alliance Management to ensure PVAs are compliant with global regulatory requirements and support the implementation and oversight of PVA obligations across the organization.
9. Contribute to standard operating procedures relevant to pharmacovigilance
10. Mentor and coach team members, foster a high-performance culture, and deliver results in a dynamic, fast-paced environment.
11. Assist with other department activities as needed.
Key Core Competencies
12. Works effectively with minimal supervision.
13. High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture.
14. Self-motivated with solid management skills, and the ability to lead or participate effectively in cross-functional teams.
15. Skilled mentoring and coaching to develop team deliverables.
16. Proficient verbal and written communication skills.
17. Proficient in MS Office applications and adaptable to technology and systems.
18. Knowledge of current US and international pharmacovigilance regulations.
19. Ability to multi-task under limited direction and on own initiative.
20. Excellent interpersonal, written and verbal communication skills.
21. 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.
22. Must have excellent customer-service orientation, high degree of professionalism, and ability to work with independently.
23. Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
Education and Experience
24. Bachelor's degree required. Preferably in a scientific, regulatory, or health-related field; advanced degree preferred.
25. Minimum 8 – 10 years of relevant experience in healthcare industry.
26. Minimum 5 years of experience specific to Pharmacovigilance operations and compliance.
27. Project leadership/management skills.
28. Excellent understanding of U.S. regulations and guidances, and a strong working knowledge of global regulations and guidances, e.g., European Economic Area, United Kingdom, and Canadian regulatory frameworks.
The base salary range for this role is $155,000 to $193,000. 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 flexible 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.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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) employer
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; 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.