Sumitomo Pharma
Associate Medical Director, Pharmacovigilance and Risk Management (PVRM)
Sumitomo Pharma, Lincoln, Nebraska, United States, 68511
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. 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 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, Informed Consent Forms, Safety Management Plans, Clinical Study Reports, Investigator’s Brochures, Investigator communications, Aggregate Reports, Company Core Data Sheets, Locally approved labels such as USPI, SmPC, and Canadian 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 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 literature evaluation, investigator site training, continuing education for internal staff, inspection readiness, audits, and inspections. Prepares and presents safety information 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 or assignments that require safety input, ensures compliance with regulations and SOPs, and fosters a culture of “Safety First” in line with SMPA’s values. Key Core Competencies
Knowledge of ICH, US & EU regulations, and requirements for Pharmacovigilance. Excellent interpersonal skills, with demonstrated ability to work in a multi-disciplinary setting, foster teamwork, and act as a facilitator to drive fulfillment of strategic goals. Willingness to be very “hands-on” in a fast-paced work environment, and 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 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. 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 the opportunity for 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 robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data: All information that an employee encounters is considered confidential. Compliance: Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities are carried out with the highest ethical standards. Equality: Sumitomo Pharma America is an Equal Employment Opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, gender, disability, veteran status or any other characteristic protected by law. Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan 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. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. Our mission, vision and values guide our work.
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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. 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 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, Informed Consent Forms, Safety Management Plans, Clinical Study Reports, Investigator’s Brochures, Investigator communications, Aggregate Reports, Company Core Data Sheets, Locally approved labels such as USPI, SmPC, and Canadian 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 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 literature evaluation, investigator site training, continuing education for internal staff, inspection readiness, audits, and inspections. Prepares and presents safety information 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 or assignments that require safety input, ensures compliance with regulations and SOPs, and fosters a culture of “Safety First” in line with SMPA’s values. Key Core Competencies
Knowledge of ICH, US & EU regulations, and requirements for Pharmacovigilance. Excellent interpersonal skills, with demonstrated ability to work in a multi-disciplinary setting, foster teamwork, and act as a facilitator to drive fulfillment of strategic goals. Willingness to be very “hands-on” in a fast-paced work environment, and 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 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. 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 the opportunity for 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 robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data: All information that an employee encounters is considered confidential. Compliance: Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities are carried out with the highest ethical standards. Equality: Sumitomo Pharma America is an Equal Employment Opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, gender, disability, veteran status or any other characteristic protected by law. Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan 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. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. Our mission, vision and values guide our work.
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