Sumitomo Pharma
Associate Medical Director, Pharmacovigilance and Risk Management (PVRM)
Sumitomo Pharma, Augusta, Maine, us, 04338
Overview
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company with key operations in the U.S., Canada, and Europe, focused on oncology, urology, women\'s health, rare diseases, psychiatry & neurology, and cell & gene therapies. The company aims to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit the SMPA website 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 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, 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 post-marketing 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 SME on behalf of PVRM for: Study Protocols, Informed Consent Forms (ICF), Safety Management Plans (SMP), Clinical Study Reports (CSR), Investigator’s 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), Locally approved labels such as USPI, SmPC, and Canadian Product Monograph (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 vendor\'s Medical PV operations group. Supports PVRM or cross-functional ad-hoc projects requiring safety input, ensuring compliance with regulations and SOPs, and fosters a culture of “Safety First” in line with SMPA values. Key Core Competencies
Knowledge of ICH, US and EU regulations, and requirements for Pharmacovigilance. Excellent interpersonal skills, with ability to work in a multi-disciplinary setting, foster teamwork, and facilitate achievement of strategic goals. Hands-on, 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 post-marketing 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 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, 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 time-off policy includes flexible paid time off, 11 paid holidays plus additional time off during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary, 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 performed by personnel in this classification and are not an exhaustive list of all responsibilities. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Compliance, Confidential Data and Equal Employment Opportunity
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 to ensure plans and activities for SMPA and affiliates are conducted with high ethical standards. 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 status, sex, gender identity or expression, disability, veteran or military status, or other protected characteristics as required by law. Mission and Vision 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 worldwide. Our Vision: For Longer and Healthier Lives, we unlock the future with cutting-edge technology and ideas.
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Sumitomo Pharma Co., Ltd. is a global pharmaceutical company with key operations in the U.S., Canada, and Europe, focused on oncology, urology, women\'s health, rare diseases, psychiatry & neurology, and cell & gene therapies. The company aims to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit the SMPA website 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 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, 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 post-marketing 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 SME on behalf of PVRM for: Study Protocols, Informed Consent Forms (ICF), Safety Management Plans (SMP), Clinical Study Reports (CSR), Investigator’s 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), Locally approved labels such as USPI, SmPC, and Canadian Product Monograph (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 vendor\'s Medical PV operations group. Supports PVRM or cross-functional ad-hoc projects requiring safety input, ensuring compliance with regulations and SOPs, and fosters a culture of “Safety First” in line with SMPA values. Key Core Competencies
Knowledge of ICH, US and EU regulations, and requirements for Pharmacovigilance. Excellent interpersonal skills, with ability to work in a multi-disciplinary setting, foster teamwork, and facilitate achievement of strategic goals. Hands-on, 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 post-marketing 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 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, 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 time-off policy includes flexible paid time off, 11 paid holidays plus additional time off during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary, 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 performed by personnel in this classification and are not an exhaustive list of all responsibilities. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Compliance, Confidential Data and Equal Employment Opportunity
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 to ensure plans and activities for SMPA and affiliates are conducted with high ethical standards. 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 status, sex, gender identity or expression, disability, veteran or military status, or other protected characteristics as required by law. Mission and Vision 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 worldwide. Our Vision: For Longer and Healthier Lives, we unlock the future with cutting-edge technology and ideas.
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