Sumitomo Pharma
Associate Medical Director, Pharmacovigilance and Risk Management (PVRM)
Sumitomo Pharma, Juneau, Alaska, us, 99812
Overview
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company with key operations in the U.S., Canada, and Europe, focused on oncology, urology, womens health, rare diseases, psychiatry & neurology, and cell & gene therapies. The company seeks to accelerate discovery, research, and development to bring novel therapies to patients sooner. 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, review of clinical trial and post-marketing 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/author safety statements as a medical safety SME on behalf of PVRM for documents and materials (e.g., Study Protocols, Informed Consent Forms, Safety Management Plans, Clinical Study Reports, Investigators Brochures, Investigator communications, aggregate reports, and local labels such as USPI, SmPC, and 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, participate in 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 (graphs, tables, and reports) to project teams and senior management regarding the safety profile of 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/SOPs, fostering a culture of Safety First. Represent and provide safety input in cross-functional settings as needed. Key Core Competencies
Knowledge of ICH, US & EU regulations and Pharmacovigilance requirements. Excellent interpersonal skills, ability to work in a multi-disciplinary setting, and ability to facilitate achievement of strategic goals. Hands-on approach in a fast-paced environment 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 is highly desired 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. Compensation & Benefits
The base salary range for this role is $180,400 to $225,500. Base salary is part of the total rewards package including merit-based increases, eligibility for our 401(k) plan, medical/dental/vision/Life and disability insurances, and leaves in line with work state. Our time-off policy includes flexible paid time off, 11 paid holidays, and additional time off for a year-end shutdown. Total compensation will depend on candidate experience, skills, education, and other factors. Disclaimer: The statements describe the general nature and level of work and are not an exhaustive list of responsibilities. Personnel may be required to perform duties outside of their normal responsibilities from time to time. Compliance & Workplace Standards
Confidential Data : All information encountered is considered confidential. Compliance : Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures for SMPA and affiliates. Equal Employment Opportunity : SMPA is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to protected characteristics as defined by law. Mental/Physical Requirements : Fast-paced environment; ability to handle multiple demands; high initiative and independence; excellent written and oral communication skills; ability to use a computer for extended periods. Sumitomo Pharma America (SMPA) : Equal Employment Opportunity (EEO) employer. #J-18808-Ljbffr
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company with key operations in the U.S., Canada, and Europe, focused on oncology, urology, womens health, rare diseases, psychiatry & neurology, and cell & gene therapies. The company seeks to accelerate discovery, research, and development to bring novel therapies to patients sooner. 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, review of clinical trial and post-marketing 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/author safety statements as a medical safety SME on behalf of PVRM for documents and materials (e.g., Study Protocols, Informed Consent Forms, Safety Management Plans, Clinical Study Reports, Investigators Brochures, Investigator communications, aggregate reports, and local labels such as USPI, SmPC, and 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, participate in 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 (graphs, tables, and reports) to project teams and senior management regarding the safety profile of 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/SOPs, fostering a culture of Safety First. Represent and provide safety input in cross-functional settings as needed. Key Core Competencies
Knowledge of ICH, US & EU regulations and Pharmacovigilance requirements. Excellent interpersonal skills, ability to work in a multi-disciplinary setting, and ability to facilitate achievement of strategic goals. Hands-on approach in a fast-paced environment 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 is highly desired 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. Compensation & Benefits
The base salary range for this role is $180,400 to $225,500. Base salary is part of the total rewards package including merit-based increases, eligibility for our 401(k) plan, medical/dental/vision/Life and disability insurances, and leaves in line with work state. Our time-off policy includes flexible paid time off, 11 paid holidays, and additional time off for a year-end shutdown. Total compensation will depend on candidate experience, skills, education, and other factors. Disclaimer: The statements describe the general nature and level of work and are not an exhaustive list of responsibilities. Personnel may be required to perform duties outside of their normal responsibilities from time to time. Compliance & Workplace Standards
Confidential Data : All information encountered is considered confidential. Compliance : Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures for SMPA and affiliates. Equal Employment Opportunity : SMPA is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to protected characteristics as defined by law. Mental/Physical Requirements : Fast-paced environment; ability to handle multiple demands; high initiative and independence; excellent written and oral communication skills; ability to use a computer for extended periods. Sumitomo Pharma America (SMPA) : Equal Employment Opportunity (EEO) employer. #J-18808-Ljbffr