Senior Medical Director, PVRM

Benefits

Additional Information

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational 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 The Pharmacovigilance and Risk Management (PVRM) Senior Medical Director will be responsible for the medical safety aspects of clinical trials including review/addressing safety queries related to protocol Informed Consent Form (ICF), Safety Management Plan (SMP), Clinical Study report (CSR), Investigator Brochure (IB) safety section etc., Also, the medical review and assessment of individual case safety reports, including seriousness, expectedness, quality of the narrative, adverse event coding and causality. The Senior Medical Director will also provide medical safety subject matter expertise in the review and approval of documents including but not limited to aggregate safety reports, including PSUR, PBRER, DSUR, PADER, Company core data sheets, local approved labels, RMP/REMS, Regulatory Authorities safety inquiries, IRB/ethics committee safety questions, Health hazard assessments. 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. This individual will perform the above duties independently and report to the VP, PVRM and Global Pharmacovigilance Head. Job Duties and Responsibilities Lead safety strategy and key messaging in NDA/BLA/MAA submissions Lead ongoing safety monitoring of assigned investigational and marketed products. Providing PVRM Medical representation on product specific and/or clinical study team meetings and governance committees. Prepare and present safety data analysis to project teams and senior management, for assigned products Evaluate safety data and contribute/author safety sections 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), and Investigator's Brochures (IB) Contribute to preparation and update of Company Core Data Sheets (CCDS), Locally labels such as, United States Prescribing Information (USPI), European Summary of Product Characteristics (SmPC), Canadian Product Monograph (PM), and Risk Management Plans (RMPs)/Risk Evaluation and Mitigation Strategy (REMS) Medical review of Aggregate Reports (PADER, PSUR, PBRER, DSUR, IND/NDA Annual Reports) Handle Health Hazard Evaluations and Ad-Hoc Regulatory safety inquiries. Perform aggregate safety data review in support of signal and trend detection activities, safety evaluation/analysis/investigation, risk benefit management and other departmental activities as appropriate. Participate/contribute to other activities such as literature evaluation, investigator site training, continuing education for internal staff, audits, and inspections. Develop and maintain strong relationship with cross-functional teams such as Clinical Development, pre-clinical Safety, Clinical Operations and Clinical Pharmacology. Maintain a working knowledge of applicable global regulatory authority regulations. Support PVRM or cross-functional ad-hoc projects or assignments that require safety input Ensure compliance with regulations/internal SOPs and fosters a culture of "Patient first" in line with SMPA's values and related behaviors. Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives, adverse event coding, concomitant medication coding, and causality statements Key Core Competencies Thorough knowledge of the pharma industry especially clinical research and global regulatory requirements and experience managing expedited and periodic safety reporting, signal generation, safety evaluation and risk managements strategies. Thorough knowledge of FDA and ICH safety reporting regulations and guidelines. Demonstrated strategic and critical thinking, strong communication skills (both oral and written) Ability to work effectively in teams, strong interpersonal skills, and the ability to lead directly or indirectly with influence. Strong problem solving, conflict resolution and analytical skills. Ability to travel both domestically and internationally as required. Demonstrate coaching skills to develop a team. High degree of organizational awareness, ability to connect the dots to unders