Samumed is a pharmaceutical platform company based in San Diego, California, focused on advancing regenerative medicine and oncology applications through research and innovation. Samumed has discovered new targets and biological processes in the Wnt pathway, allowing the company to develop small molecule drugs that have the potential to address numerous degenerative conditions as well as many forms of cancer. Samumed is currently conducting clinical trials for five disease areas - osteoarthritis, androgenetic alopecia, oncology, degenerative disc disease and idiopathic pulmonary fibrosis - and has a broad pipeline targeting areas of significant unmet medical need.
Job Description and Responsibilities:
Responsible for medical review, processing and evaluation of safety information and adverse event reports for both investigational medicinal products. Also responsible for implementation and maintenance of safety systems and SOPs. Performs scientific review and evaluation of individual and aggregate adverse events reports, and assesses them in accordance with appropriate regulations/guidelines and internal procedures. Supports company in all phases of drug safety operations to assure compliance with appropriate domestic and international regulations, as applicable.
• Perform signal detection and management for all studies and products, working closely with Biostatistics and Data Management teams;
• Draft and support generation and maintenance of drug safety processes, SOPs, guidance documents and policies;
• Implement and maintain drug safety systems, evaluate internal vs. outsourced solutions;
• Develop Drug Safety components of the aggregate safety reports for all studies and products and of Risk Management Plans/Risk Evaluation and Mitigation Strategies, and report review;
• Perform medical review of AEs/ADRs for both marketed and pre-marketed products and medical device reports, interfacing with reporters as needed;
• Maintain Core Safety Information up-to-date, cooperate in revision of Core Safety Data Sheets and support Regulatory Affairs for product labeling;
• Ensure appropriateness of safety sections of Clinical Trial Protocols and PASS documents, and consistency of safety profile amongst different regulated documents and reports;
• Perform literature review for safety data relevant to products;
• Provide scientific input to answer safety-related questions from Regulators or to support Company internally;
• Evaluate causal relationship between the AEs/ADRs and the administration of Company products, providing scientifically sound medical comments;
• Assist in representing Company during regulatory audits and inspections;
• Prepare and Review medical documents and respond to ad hoc safety queries from Regulatory Authorities.
The following requirements are representative of the core competencies required:
• Clinical experience and/or pharmacological background;
• Medical knowledge of methods to assess causality relationship between adverse events and administration of Company products;
• Knowledge of safety databases and common software applications;
• Knowledge of MedDRA terminology, logics/structure, Standardized Queries;
• Knowledge of US CFR, EMA and ICH Guidelines on pre- and post-marketing surveillance and medical device reporting;
• Ability to evaluate, interpret and synthesize complex safety data;
• Effective oral and written communication skills;
• Cooperation and teamwork skills;
• Analytical, assessment and problem solving skills;
• Ability to accomplish objectives and timelines;
• Ability to make responsible decisions to protect Company’s liability exposure;
• Ability to promptly manage urgent and unexpected crisis safety situations/alarms.
• Medical, Nursing or Pharm.D. degree; clinical experience a plus;
• Post graduate training and/or epidemiology experience preferred;
• A minimum of 7 years of experience in the pharmaceutical industry or CRO, with 5 years in drug safety operations, pharmacovigilance and risk assessment.