Sumitomo Pharma
Overview
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S., Canada and Europe focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. The organization aims to accelerate discovery, research, and development to bring novel therapies to patients sooner. Job Overview
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Medical Director. The Associate Medical Director will provide hands-on PVRM support for SMPA investigational and commercial products. The incumbent will provide medical safety support for safety signal management throughout the product lifecycle including signal detection, signal validation, signal escalation, development of risk mitigation strategies and authoring of signal evaluation reports according to established safety governance policies and keeping senior leadership informed of safety issues. Responsibilities
Continuous monitoring and ongoing risk/benefit assessment for assigned investigational and marketed products.
Conduct safety surveillance over product life cycle, reviewing clinical trial and postmarketing Individual Case Safety Reports (ICSRs), including Adverse Event Reports (AEs), Serious Adverse Event Reports (SAEs), and Product Complaints (PCs).
Contributes to medical safety of clinical trials, including monitoring of clinical trial safety and laboratory data.
Generates safety queries, evaluates safety data and contributes/authors safety statements as a medical safety subject matter expert on behalf of PVRM for study protocols, informed consent forms (ICF), Safety Management Plans (SMP), Clinical Study Reports (CSR), Investigators Brochures (IB), Investigator communications (Dear Health Care Provider letters - DHCP), Aggregate Reports (PADER, PSUR, PBRER, DSUR, IND/NDA Annual Reports), Company Core Data Sheets (CCDS), and locally approved labels such as USPI, SmPC, and Product Monographs.
Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives, adverse event coding, concomitant medication coding, and causality statements.
Contributes to Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategy (REMS).
Contributes to PVRM and cross-functional drug development teams and manages Safety Charters.
Handles Health Hazard Evaluations and ad-hoc regulatory safety inquiries.
Represents PVRM on post-marketing product-specific and/or clinical study team meetings and governance committees.
Performs aggregate review of post-marketing safety data in support of safety signal validation, trend detection, risk-benefit management, and development of risk mitigation strategies.
Ensure timely submission of periodic aggregate ADR reporting for clinical trials and post-marketing experience as required by local and global regulations.
Participates in or contributes to other activities such as literature evaluation, investigator site training, continuing education for internal staff, inspection readiness, audits, and inspections.
Prepares and presents safety information (e.g., safety graphs, tables, and reports) to project teams and senior management, pertaining to the safety profile of therapeutically assigned compounds/products.
Reviews and updates PVRM Standard Operating Procedures and process improvements as needed.
Manages external vendor Medical PV operations groups for PVRM.
Supports PVRM or cross-functional ad-hoc projects requiring safety input, ensuring regulatory and SOP compliance, and promoting a culture of safety.
Key Core Competencies
Knowledge of ICH, US and EU regulations and requirements for Pharmacovigilance.
Excellent interpersonal skills with ability to work in a multidisciplinary setting, foster teamwork, and facilitate achievement of strategic goals.
Willingness to be hands-on in a fast-paced environment and ability to reprioritize as needed.
Strong written and spoken English communication skills.
Education and Experience
Medical Degree (MD) with 35 years of drug safety experience in a pharmaceutical company.
Experience in Oncology and Neurology is preferred.
Advanced understanding of pharmacovigilance and risk management regulations and guidelines, including pre- and post-marketing US FDA and EU ICH safety requirements.
Expertise in medical review of individual case safety reports and aggregate safety reports.
Knowledge of drug development in the pharmaceutical industry, including clinical research and global regulatory requirements.
Experience managing safety data, expedited individual and aggregate periodic safety reporting, signal generation, safety evaluation and risk management and mitigation strategies.
The base salary range for this role is $180,400 to $225,500. Base salary is part of our total rewards package which also includes merit-based salary increases, incentive participation, 401(k) eligibility, medical, dental, vision, life and disability insurances, and leaves in line with work state. Our time-off policy includes flexible paid time off, holidays, paid sick time and other leave specifics as applicable. Total compensation will depend on candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements describe the general nature and level of work but are not exhaustive of all responsibilities, duties, and skills. All personnel may be required to perform duties outside of their normal responsibilities from time to time. Confidential Data: All information encountered is considered confidential. Compliance: Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures to ensure best industry practices and ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment. Violations may be subject to penalties and liability. Mental/Physical Requirements: Fast-paced environment handling multiple demands. Requires initiative, independence, and excellent communication skills. Ability to use a PC for extended periods. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, gender identity, disability, veteran status or any other characteristic protected by law. #J-18808-Ljbffr
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S., Canada and Europe focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. The organization aims to accelerate discovery, research, and development to bring novel therapies to patients sooner. Job Overview
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Medical Director. The Associate Medical Director will provide hands-on PVRM support for SMPA investigational and commercial products. The incumbent will provide medical safety support for safety signal management throughout the product lifecycle including signal detection, signal validation, signal escalation, development of risk mitigation strategies and authoring of signal evaluation reports according to established safety governance policies and keeping senior leadership informed of safety issues. Responsibilities
Continuous monitoring and ongoing risk/benefit assessment for assigned investigational and marketed products.
Conduct safety surveillance over product life cycle, reviewing clinical trial and postmarketing Individual Case Safety Reports (ICSRs), including Adverse Event Reports (AEs), Serious Adverse Event Reports (SAEs), and Product Complaints (PCs).
Contributes to medical safety of clinical trials, including monitoring of clinical trial safety and laboratory data.
Generates safety queries, evaluates safety data and contributes/authors safety statements as a medical safety subject matter expert on behalf of PVRM for study protocols, informed consent forms (ICF), Safety Management Plans (SMP), Clinical Study Reports (CSR), Investigators Brochures (IB), Investigator communications (Dear Health Care Provider letters - DHCP), Aggregate Reports (PADER, PSUR, PBRER, DSUR, IND/NDA Annual Reports), Company Core Data Sheets (CCDS), and locally approved labels such as USPI, SmPC, and Product Monographs.
Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives, adverse event coding, concomitant medication coding, and causality statements.
Contributes to Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategy (REMS).
Contributes to PVRM and cross-functional drug development teams and manages Safety Charters.
Handles Health Hazard Evaluations and ad-hoc regulatory safety inquiries.
Represents PVRM on post-marketing product-specific and/or clinical study team meetings and governance committees.
Performs aggregate review of post-marketing safety data in support of safety signal validation, trend detection, risk-benefit management, and development of risk mitigation strategies.
Ensure timely submission of periodic aggregate ADR reporting for clinical trials and post-marketing experience as required by local and global regulations.
Participates in or contributes to other activities such as literature evaluation, investigator site training, continuing education for internal staff, inspection readiness, audits, and inspections.
Prepares and presents safety information (e.g., safety graphs, tables, and reports) to project teams and senior management, pertaining to the safety profile of therapeutically assigned compounds/products.
Reviews and updates PVRM Standard Operating Procedures and process improvements as needed.
Manages external vendor Medical PV operations groups for PVRM.
Supports PVRM or cross-functional ad-hoc projects requiring safety input, ensuring regulatory and SOP compliance, and promoting a culture of safety.
Key Core Competencies
Knowledge of ICH, US and EU regulations and requirements for Pharmacovigilance.
Excellent interpersonal skills with ability to work in a multidisciplinary setting, foster teamwork, and facilitate achievement of strategic goals.
Willingness to be hands-on in a fast-paced environment and ability to reprioritize as needed.
Strong written and spoken English communication skills.
Education and Experience
Medical Degree (MD) with 35 years of drug safety experience in a pharmaceutical company.
Experience in Oncology and Neurology is preferred.
Advanced understanding of pharmacovigilance and risk management regulations and guidelines, including pre- and post-marketing US FDA and EU ICH safety requirements.
Expertise in medical review of individual case safety reports and aggregate safety reports.
Knowledge of drug development in the pharmaceutical industry, including clinical research and global regulatory requirements.
Experience managing safety data, expedited individual and aggregate periodic safety reporting, signal generation, safety evaluation and risk management and mitigation strategies.
The base salary range for this role is $180,400 to $225,500. Base salary is part of our total rewards package which also includes merit-based salary increases, incentive participation, 401(k) eligibility, medical, dental, vision, life and disability insurances, and leaves in line with work state. Our time-off policy includes flexible paid time off, holidays, paid sick time and other leave specifics as applicable. Total compensation will depend on candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements describe the general nature and level of work but are not exhaustive of all responsibilities, duties, and skills. All personnel may be required to perform duties outside of their normal responsibilities from time to time. Confidential Data: All information encountered is considered confidential. Compliance: Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures to ensure best industry practices and ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment. Violations may be subject to penalties and liability. Mental/Physical Requirements: Fast-paced environment handling multiple demands. Requires initiative, independence, and excellent communication skills. Ability to use a PC for extended periods. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, gender identity, disability, veteran status or any other characteristic protected by law. #J-18808-Ljbffr