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, women's health, rare diseases, psychiatry and neurology, and cell and 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 or follow us on LinkedIn. Job Title
Associate Medical Director 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 ICSRs, including AEs, SAEs, and 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 SME on behalf of PVRM for: Study Protocols, ICF, SMP, CSR, IB, investigator communications, aggregate reports (PADER, PSUR, PBRER, DSUR, IND/NDA Annual Reports), CCDS, locally approved labels such as USPI, SmPC, and Canadian PM.
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 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/contributes to other activities such as literature evaluation, investigator site training, continuing education for internal staff, inspection/audit 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 enhancements as needed.
Manages PVRM external vendors Medical PV operations group.
Supports PVRM or cross-functional ad-hoc projects or assignments that require safety input, ensures compliance with regulations/SOPs, and fosters a culture of Safety First.
Key Core Competencies
Knowledge of ICH, US & EU regulations, and requirements for Pharmacovigilance.
Excellent interpersonal skills, with ability to work in a multi-disciplinary setting, foster teamwork, and drive fulfillment of strategic goals.
Hands-on approach in a fast-paced environment with ability to reprioritize as needed.
Strong communication skills with excellent written and spoken English.
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 reporting, signal generation, safety evaluation, and risk management and mitigation strategies.
Compensation and Benefits
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, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances, and leaves provided in line with work state. Our time-off policy includes flexible paid time off, 11 paid holidays, additional time off during the December shut-down, and paid sick time. Other Information
Disclaimer: This description describes the general nature and level of work performed by people assigned to this classification. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data: All information encountered is considered confidential. Compliance: Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment. Equal Employment Opportunity: Sumitomo Pharma America (SMPA) is an EEO employer and qualified applicants will receive consideration without regard to protected characteristics. Sumitomo Pharma America and Mission
Sumitomo Pharma America is committed to its mission and values as described on our site. Our mission is to contribute to society through value creation based on innovative research and development activities for better healthcare worldwide. Our vision is to enable longer and healthier lives through cutting-edge technology and ideas. #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, women's health, rare diseases, psychiatry and neurology, and cell and 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 or follow us on LinkedIn. Job Title
Associate Medical Director 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 ICSRs, including AEs, SAEs, and 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 SME on behalf of PVRM for: Study Protocols, ICF, SMP, CSR, IB, investigator communications, aggregate reports (PADER, PSUR, PBRER, DSUR, IND/NDA Annual Reports), CCDS, locally approved labels such as USPI, SmPC, and Canadian PM.
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 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/contributes to other activities such as literature evaluation, investigator site training, continuing education for internal staff, inspection/audit 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 enhancements as needed.
Manages PVRM external vendors Medical PV operations group.
Supports PVRM or cross-functional ad-hoc projects or assignments that require safety input, ensures compliance with regulations/SOPs, and fosters a culture of Safety First.
Key Core Competencies
Knowledge of ICH, US & EU regulations, and requirements for Pharmacovigilance.
Excellent interpersonal skills, with ability to work in a multi-disciplinary setting, foster teamwork, and drive fulfillment of strategic goals.
Hands-on approach in a fast-paced environment with ability to reprioritize as needed.
Strong communication skills with excellent written and spoken English.
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 reporting, signal generation, safety evaluation, and risk management and mitigation strategies.
Compensation and Benefits
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, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances, and leaves provided in line with work state. Our time-off policy includes flexible paid time off, 11 paid holidays, additional time off during the December shut-down, and paid sick time. Other Information
Disclaimer: This description describes the general nature and level of work performed by people assigned to this classification. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data: All information encountered is considered confidential. Compliance: Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment. Equal Employment Opportunity: Sumitomo Pharma America (SMPA) is an EEO employer and qualified applicants will receive consideration without regard to protected characteristics. Sumitomo Pharma America and Mission
Sumitomo Pharma America is committed to its mission and values as described on our site. Our mission is to contribute to society through value creation based on innovative research and development activities for better healthcare worldwide. Our vision is to enable longer and healthier lives through cutting-edge technology and ideas. #J-18808-Ljbffr