Senior Manager, Drug Safety and Medical Monitoring

Senior Manager Of Drug Safety And Medical MonitorSupernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 8 products in the market that are making a real impact on patient outcomes.Job Summary:The Senior Manager of Drug Safety and Medical Monitor will provide medical monitoring support to the drug safety and medical monitoring team. They will conduct medical reviews of clinical research data, safety alerts and notification, SAE narratives, and pertinent source documents. Responsibilities also include reviewing and processing documents relevant to medical monitoring activities and providing medical input to internal teams such as Clinical Development, Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, and Medical Writing.Essential Duties & Responsibilities:Conduct medical reviews of clinical trial safety data and provide input to internal teams (Clinical Development, Drug Safety, Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, Medical Affairs, and Medical Writing).Conduct medical reviews of clinical trial documents including clinical trial protocols, informed consent forms, Investigator's Brochure and other essential study documents and plans, and provide input to Clinical Development, Medical Writing, and Clinical Operations teams.Conduct medical reviews and perform user acceptance testing of electronic case report forms (eCRF) to ensure medical consistency of clinical and safety data collection.Draft, review, and maintain clinical trial forms (e.g., eligibility forms, FAQs/Medical Monitoring Logs, Medical Review Summary Forms) and file them in appropriate folders (e.g., Trial Master File, shared drive, etc.) for all applicable clinical trials.Conduct medical reviews of Tables/Listings/Figures (TLF), clinical study reports (CSR), and provide input to Clinical Development, Medical Writing, Data Management and Clinical Operations Teams.Review, categorize, and maintain the Medical Monitoring Outlook folder.Review and file safety alerts and notifications and communicate notable values to the Medical Monitoring Lead.Track and ensure timely review of the protocol deviations for all applicable clinical trials.Review coding to ensure accuracy of MedDRA coding for adverse event terms, medical history, and procedures, and WHO Drug coding for concomitant medications.Conduct medical reviews of Individual Case Safety Reports (ICSRs), including Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Adverse Drug Reactions (ADRs), causality assessments, signal detection, case narratives, aggregate reports, and safety data listings, and communicate all applicable comments to the Pharmacovigilance Lead.Prepare and review Medical Monitoring Plans and Safety Management Plans, and participate in Site Initiation Visits.Provide medical input and review of annual reports, PADERs, PSURs, DSURs, other benefit-risk assessment reports, updates to package inserts/labels, and Summaries of Product Characteristics (SmPCs).Participate in and present at Clinical Development training and meetings; prepare meeting agendas and minutes, as applicable.Draft and review Standard Operating Procedures (SOPs).Review Statements of Work and vendor budgets for all applicable medical monitoring tasks and escalate issues to relevant team members.Support the Drug Safety and Medical Monitoring team in the preparation and review of safety reports and data, e.g., cumulative SAE reports, safety database reports, MedWatch Reports, and other reports, as deemed necessary.Maintain up-to-date knowledge of all applicable drug safety guidelines and regulations (FDA, ICH, MHRA, EMA) and apply them to medical monitoring tasks relevant to disease areas and therapeutic areas for both marketed drugs and drugs in development.Ensure compliance with clinical protocol safety objectives, policies, processes, and proceduresPerform other duties as assigned.Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law. Supernus Pharmaceuticals