Sumitomo Pharma
Associate Medical Director, PVRM
Sumitomo Pharma, Oklahoma City, Oklahoma, United States, 73116
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 & 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 https://www.us.sumitomo-pharma.com and 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)
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 subject matter expert (SME) on behalf of PVRM for: Study Protocols, Informed Consent Forms (ICF), Safety Management Plans (SMP), Clinical Study Reports (CSR), Investigators 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, United States Prescribing Information (USPI), European Summary of Product Characteristics (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)/Risk Evaluation and Mitigation Strategy (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/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 (i.e. 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/internal SOPs, and fosters a culture of Safety First in line with SMPAs values and related behaviors.
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/nurture 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 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 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.
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, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected 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, women's 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 https://www.us.sumitomo-pharma.com and 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)
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 subject matter expert (SME) on behalf of PVRM for: Study Protocols, Informed Consent Forms (ICF), Safety Management Plans (SMP), Clinical Study Reports (CSR), Investigators 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, United States Prescribing Information (USPI), European Summary of Product Characteristics (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)/Risk Evaluation and Mitigation Strategy (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/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 (i.e. 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/internal SOPs, and fosters a culture of Safety First in line with SMPAs values and related behaviors.
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/nurture 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 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 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.
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, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #J-18808-Ljbffr