Senior Manager, Drug Safety and Medical Monitor

Senior Manager, Drug Safety and Medical Monitor Requisition Number: SENIO001675 Apply now Full-Time Hybrid Locations Showing 1 location Rockville, MD 20850, USA Description Supernus 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. 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 elevate 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 procedures. Perform other duties as assigned. Supervisory Responsibilities: N/A. Knowledge & Other Qualifications: Degree in a medical field, MD, DO, MBBS, Nurse Practitioner, or equivalent is required with a minimum of three years of relevant experience. Knowledge of medical and therapeutic terminology, including WHO Drug and MedDRA dictionaries. Experience in medical monitoring and medical review. Experience in authoring Standard Operating Procedures. Experience with clinical and safety databases, and Veeva Systems. Working knowledge of ICH guidelines and other global safety regulations. Demonstrated working knowledge of FDA regulations relevant to patient safety and adverse event reporting, including periodic safety reporting. Working knowledge of principles and concepts associated with patient safety case-handling processes, including regulatory reporting requirements, policies, processes, and procedures. Other Characteristics: Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality. Ability to have an innovative and dynamic approach to work. A self-starter able to work independently but comfortable working in a team environment. Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others. Capable of performing other duties as assigned by Management. Authorized to legally work in the United States without visa sponsorship. Physical Requirements/Work Environment/Travel Requirements: Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time. The worker is required to have close visual acuity to perform activities such as preparing and analyzing data and figures, transcribing, viewing a computer screen, iPad, or other electronic device, and extensive reading. Strong attention to detail is essential to ensure accuracy and consistency in all tasks involving data review and documentation. The worker is not substantially exposed to adverse environmental conditions. Compensation: At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $131,000 to $155,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual’s salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs. You also will be able to participate in a competitive benefits package, including but not limited to: health, dental, vision, paid time off, 401k company match, company paid life insurance and health and wellness benefits. The total compensation package for this position also includes other compensation elements such as stock equity awards, employee stock purchase programs and participation in our Company’s discretionary annual bonus program. 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. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor. #J-18808-Ljbffr Supernus Pharmaceuticals Inc