Senior Manager Drug Safety and Medical Monitor

Senior Manager Drug Safety and Medical Monitor

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 on the market that are making a real impact on patient outcomes.

The Senior Manager of Drug Safety and Medical Monitoring 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 notifications, 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).
• Review and process clinical trial documents including 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.
• 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 for all applicable trials.
• Review medical tables, listings, and 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 protocol deviations for all applicable 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, serious adverse events, adverse events of special interest, adverse drug reactions, 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 raise 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, Med Watch 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 and investigational drugs.
• Ensure compliance with clinical protocol safety objectives, policies, processes, and procedures.
• Perform other duties as assigned.

• N/A.

• Degree in a medical field (MD, DO, MBBS, Nurse…