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 Pharmacovigilance and Risk Management (PVRM) Associate Director serves as the PVRM point of contact for cross-functional, global development, and strategic partnership co-development teams while leading safety surveillance activities, including signal detection, evaluation, and risk management activities and ensuring adherence to safety governance for assigned compounds/products. This role will report to the Director, Pharmacovigilance and Risk Management (PVRM).
**Job Duties and Responsibilities**
+ Supports Drug Safety Physician's Safety Governance efforts by leading cross-functional Safety Management Team (SMT) assessing drug safety profiles and providing safety guidance and input to key safety documents, including IBs, ICFs, protocols, study reports, regulatory reports, and responses to regulatory requests.
+ Leads/contributes to signal detection, monitoring, evaluation, interpretation, escalation, and appropriate communication of safety information through established safety governance.
+ Maintains continuous monitoring and updates of safety profiles for assigned investigational and marketed products and ongoing risk/benefit assessment for investigational/marketed products.
+ Serves as point of contact for and collaborates with colleagues from Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and other related departments. Represent PVRM at cross-functional Steering Committee meetings or corporate partner-related meetings -Joint Safety Forums (JSFs) and PVC.
+ Performs Review of adverse event reports, including but not limited to all serious events of interest, and expedited individual case safety reports, ensuring that appropriate interpretation, consistency, and quality are applied to adverse event case assessment on individual and aggregate levels. Generates or assists with input to Analysis of Similar Events, if required.
+ Performs review of coding (e.g., reaction, suspect/concomitant product, indication, laboratory data, medical history). Provides support for investigator brochures, protocols, informed consent, final study reports, and other safety-relevant documents as appropriate.
+ Leads early identification of safety issues that require Safety Governance escalation from Safety Management Teams (SMTs) to Therapeutic Area Safety Committees (TASCs) and/or the Executive Safety Committee (ESC). Serves as SMT Chair/Quorum member for assigned products.
+ Serves as subject matter expert in study protocol design, review of interim reports for ongoing clinical trials, clinical study reports, safety summary documents, and responses to regulatory requests.
+ Prepares and may present individual case safety report issues, aggregate data analyses and interpretation, strategies for submission documents such as the ISS and SCS, and proposed risk mitigation strategies for discussion at internal meetings.
+ Provides input to key internal safety documents, including Risk Management documents (REMS, RMPs), development, and updates/maintenance of expectedness guides.
+ Work collaboratively with PV and cross-functional team members to manage the benefit/risk profile of assigned products and ensure patient safety.
+ Review Literature search strategy and perform literature monitoring (with vendor support) and ensure appropriate sources are incorporated into signal detection activities **.**
+ Participate in aggregate safety report activities, including data compilation and analysis, as well as the writing of assigned sections (with vendor support).
+ Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests.
+ Serve as a subject matter expert in PVRM within the assigned program(s) as well as the larger SMPA organization (R&D and Commercial).Other Activities may include, as requested:
+ Develop Standard Operating Procedures, Work Instructions, and other controlled documents.
+ Contribute to internal departmental and/or cross-functional inspection readiness and operational improvement activities.
+ Support collaboration with external partners.
+ Supports PVRM or cross-functional ad-hoc projects or assignments that require safety input, ensures compliance with regulations/internal SOPs, and fosters a culture of "Patient First" in line with SMPA's values and related behaviors.
**Key Core Competencies**
+ Proven ability to investigate and resolve complex safety-related issues and make/evaluate proposals for appropriate corrective action.
+ Good understanding of global drug safety dynamics and experience with risk mitigation strategies preferred.
+ Experience with FDA/EU and/or other regulatory agencies, preparing safety reports for health agencies and authorities both domestically and globally.
+ Demonstrated skills working within a matrix environment.
+ Ability to work collaboratively with others within and external to the company.
+ Strong communication skills with excellent written and spoken English.
+ Ability to work independently and productively and set priorities across multiple projects with little supervision.
+ Excellent interpersonal skills with demonstrated ability to work in a multi-disciplinary setting and foster teamwork.
+ Demonstrate coaching skills to develop the team as appropriate.
+ Presentation skills.
**Education and Experience**
+ Minimum 8+ years of Pharmacovigilance and Risk Management experience required.
+ Prior oncology industry experience preferred.
+ Experience with early phase development preferred.
+ Experience working on a fasted paced dynamic environment.
+ Prior leadership or project management experience strongly preferred.
The base salary range for this role is $155,000 to $193,800. 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.
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.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
SMPA may use Artificial Intelligence ("AI") as part of the job application process, including to assist us in evaluating your application. By submitting your information, you acknowledge that the company may use AI tools as part of our evaluation.
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_
The Pharmacovigilance and Risk Management (PVRM) Associate Director serves as the PVRM point of contact for cross-functional, global development, and strategic partnership co-development teams while leading safety surveillance activities, including signal detection, evaluation, and risk management activities and ensuring adherence to safety governance for assigned compounds/products. This role will report to the Director, Pharmacovigilance and Risk Management (PVRM).
**Job Duties and Responsibilities**
+ Supports Drug Safety Physician's Safety Governance efforts by leading cross-functional Safety Management Team (SMT) assessing drug safety profiles and providing safety guidance and input to key safety documents, including IBs, ICFs, protocols, study reports, regulatory reports, and responses to regulatory requests.
+ Leads/contributes to signal detection, monitoring, evaluation, interpretation, escalation, and appropriate communication of safety information through established safety governance.
+ Maintains continuous monitoring and updates of safety profiles for assigned investigational and marketed products and ongoing risk/benefit assessment for investigational/marketed products.
+ Serves as point of contact for and collaborates with colleagues from Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and other related departments. Represent PVRM at cross-functional Steering Committee meetings or corporate partner-related meetings -Joint Safety Forums (JSFs) and PVC.
+ Performs Review of adverse event reports, including but not limited to all serious events of interest, and expedited individual case safety reports, ensuring that appropriate interpretation, consistency, and quality are applied to adverse event case assessment on individual and aggregate levels. Generates or assists with input to Analysis of Similar Events, if required.
+ Performs review of coding (e.g., reaction, suspect/concomitant product, indication, laboratory data, medical history). Provides support for investigator brochures, protocols, informed consent, final study reports, and other safety-relevant documents as appropriate.
+ Leads early identification of safety issues that require Safety Governance escalation from Safety Management Teams (SMTs) to Therapeutic Area Safety Committees (TASCs) and/or the Executive Safety Committee (ESC). Serves as SMT Chair/Quorum member for assigned products.
+ Serves as subject matter expert in study protocol design, review of interim reports for ongoing clinical trials, clinical study reports, safety summary documents, and responses to regulatory requests.
+ Prepares and may present individual case safety report issues, aggregate data analyses and interpretation, strategies for submission documents such as the ISS and SCS, and proposed risk mitigation strategies for discussion at internal meetings.
+ Provides input to key internal safety documents, including Risk Management documents (REMS, RMPs), development, and updates/maintenance of expectedness guides.
+ Work collaboratively with PV and cross-functional team members to manage the benefit/risk profile of assigned products and ensure patient safety.
+ Review Literature search strategy and perform literature monitoring (with vendor support) and ensure appropriate sources are incorporated into signal detection activities **.**
+ Participate in aggregate safety report activities, including data compilation and analysis, as well as the writing of assigned sections (with vendor support).
+ Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests.
+ Serve as a subject matter expert in PVRM within the assigned program(s) as well as the larger SMPA organization (R&D and Commercial).Other Activities may include, as requested:
+ Develop Standard Operating Procedures, Work Instructions, and other controlled documents.
+ Contribute to internal departmental and/or cross-functional inspection readiness and operational improvement activities.
+ Support collaboration with external partners.
+ Supports PVRM or cross-functional ad-hoc projects or assignments that require safety input, ensures compliance with regulations/internal SOPs, and fosters a culture of "Patient First" in line with SMPA's values and related behaviors.
**Key Core Competencies**
+ Proven ability to investigate and resolve complex safety-related issues and make/evaluate proposals for appropriate corrective action.
+ Good understanding of global drug safety dynamics and experience with risk mitigation strategies preferred.
+ Experience with FDA/EU and/or other regulatory agencies, preparing safety reports for health agencies and authorities both domestically and globally.
+ Demonstrated skills working within a matrix environment.
+ Ability to work collaboratively with others within and external to the company.
+ Strong communication skills with excellent written and spoken English.
+ Ability to work independently and productively and set priorities across multiple projects with little supervision.
+ Excellent interpersonal skills with demonstrated ability to work in a multi-disciplinary setting and foster teamwork.
+ Demonstrate coaching skills to develop the team as appropriate.
+ Presentation skills.
**Education and Experience**
+ Minimum 8+ years of Pharmacovigilance and Risk Management experience required.
+ Prior oncology industry experience preferred.
+ Experience with early phase development preferred.
+ Experience working on a fasted paced dynamic environment.
+ Prior leadership or project management experience strongly preferred.
The base salary range for this role is $155,000 to $193,800. 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.
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.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
SMPA may use Artificial Intelligence ("AI") as part of the job application process, including to assist us in evaluating your application. By submitting your information, you acknowledge that the company may use AI tools as part of our evaluation.
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_