Sumitomo Pharma
Overview
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, womens health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website (references omitted in this formatted version) or follow us on LinkedIn. 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 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. Job Duties and 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). Contribute to medical safety of clinical trials, including monitoring of clinical trial safety and laboratory data. Generate safety queries, evaluate safety data, and contribute/authors safety statements as a medical safety SME on behalf of PVRM for study protocols, ICFs, safety management plans, CSR, IB, investigator communications, aggregate reports, CCDS, local labels such as USPI, SmPC, and Canadian PM. Ensure timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives, adverse event coding, concomitant medication coding, and causality statements. Contribute to Risk Management Plans (RMPs) / REMS. Contribute to PVRM and cross-functional drug development teams and manage Safety Charters. Handle health hazard evaluations and ad-hoc regulatory safety inquiries. Represent PVRM on post-marketing product specific and/or clinical study team meetings and governance committees. Perform 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. Participate in literature evaluation, investigator site training, continuing education for internal staff, inspection/audit readiness, audits, and inspections. Prepare and present 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. Review and update PVRM Standard Operating Procedures and process enhancements as needed. Manage PVRM external vendors Medical PV operations group. Support PVRM or cross-functional ad-hoc projects requiring safety input and ensure compliance with regulations and SOPs, fostering a culture of Safety First. Key Core Competencies
Knowledge of ICH, US & EU regulations, and requirements for Pharmacovigilance. Excellent interpersonal skills and ability to work in a multi-disciplinary setting, foster teamwork, and drive strategic goals. Hands-on, fast-paced work style with ability to reprioritize as needed. Strong written and spoken English communication skills. Education and Experience
Medical Degree (MD) with 3-5 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 postmarketing US FDA and/or 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 plans, 401(k) plan eligibility, medical/dental/vision, life and disability insurances, and leaves in line with work state. Time-off policy includes flexible paid time off, 11 paid holidays plus time off during a year-end shutdown, and 80 hours of paid sick time on hire and thereafter. Total compensation will depend on candidate experience, skills, and education. EEO statements and compliance: Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration without regard to protected characteristics as defined by law. #J-18808-Ljbffr
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, womens health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website (references omitted in this formatted version) or follow us on LinkedIn. 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 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. Job Duties and 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). Contribute to medical safety of clinical trials, including monitoring of clinical trial safety and laboratory data. Generate safety queries, evaluate safety data, and contribute/authors safety statements as a medical safety SME on behalf of PVRM for study protocols, ICFs, safety management plans, CSR, IB, investigator communications, aggregate reports, CCDS, local labels such as USPI, SmPC, and Canadian PM. Ensure timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives, adverse event coding, concomitant medication coding, and causality statements. Contribute to Risk Management Plans (RMPs) / REMS. Contribute to PVRM and cross-functional drug development teams and manage Safety Charters. Handle health hazard evaluations and ad-hoc regulatory safety inquiries. Represent PVRM on post-marketing product specific and/or clinical study team meetings and governance committees. Perform 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. Participate in literature evaluation, investigator site training, continuing education for internal staff, inspection/audit readiness, audits, and inspections. Prepare and present 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. Review and update PVRM Standard Operating Procedures and process enhancements as needed. Manage PVRM external vendors Medical PV operations group. Support PVRM or cross-functional ad-hoc projects requiring safety input and ensure compliance with regulations and SOPs, fostering a culture of Safety First. Key Core Competencies
Knowledge of ICH, US & EU regulations, and requirements for Pharmacovigilance. Excellent interpersonal skills and ability to work in a multi-disciplinary setting, foster teamwork, and drive strategic goals. Hands-on, fast-paced work style with ability to reprioritize as needed. Strong written and spoken English communication skills. Education and Experience
Medical Degree (MD) with 3-5 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 postmarketing US FDA and/or 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 plans, 401(k) plan eligibility, medical/dental/vision, life and disability insurances, and leaves in line with work state. Time-off policy includes flexible paid time off, 11 paid holidays plus time off during a year-end shutdown, and 80 hours of paid sick time on hire and thereafter. Total compensation will depend on candidate experience, skills, and education. EEO statements and compliance: Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration without regard to protected characteristics as defined by law. #J-18808-Ljbffr