Sumitomo Pharma
Associate Medical Director, Pharmacovigilance and Risk Management (PVRM)
Sumitomo Pharma, Dover, Delaware, United States, 19904
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. We aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. Job Overview
We are 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 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 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 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) / 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 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 requiring safety input, ensuring compliance with regulations/SOPs, and fostering 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 strategic goals. Willingness to be very hands-on in a fast-paced environment, and 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 US FDA and EU ICH safety requirements Expertise in medical review of ICSRs 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
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. Our 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 will depend on experience, skills, education, and other factors permitted by law. Disclaimer: The above statements describe the general nature and level of work and are not exhaustive. All personnel may be required to perform duties outside of their normal responsibilities. Equal Employment Opportunity (EEO): Sumitomo Pharma America is an equal 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 protected characteristic. Sumitomo Pharma America and Sumitomo Pharma Co., Ltd. are global pharmaceutical companies with operations in the U.S., Canada and Europe focused on oncology, urology, womenu2019s health, rare diseases, psychiatry & neurology, and cell & gene therapies. #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, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. We aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. Job Overview
We are 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 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 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 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) / 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 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 requiring safety input, ensuring compliance with regulations/SOPs, and fostering 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 strategic goals. Willingness to be very hands-on in a fast-paced environment, and 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 US FDA and EU ICH safety requirements Expertise in medical review of ICSRs 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
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. Our 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 will depend on experience, skills, education, and other factors permitted by law. Disclaimer: The above statements describe the general nature and level of work and are not exhaustive. All personnel may be required to perform duties outside of their normal responsibilities. Equal Employment Opportunity (EEO): Sumitomo Pharma America is an equal 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 protected characteristic. Sumitomo Pharma America and Sumitomo Pharma Co., Ltd. are global pharmaceutical companies with operations in the U.S., Canada and Europe focused on oncology, urology, womenu2019s health, rare diseases, psychiatry & neurology, and cell & gene therapies. #J-18808-Ljbffr