Associate Medical Director, Pharmacovigilance and Risk Management (PVRM)

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 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 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 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), 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, 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 vendor’s 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 -SMPA’s values and related behaviors.

Key Core Competencies

• Knowledge of