Senior Manager, Drug Safety

Role Summary

The Senior Manager of Drug Safety will support drug safety and pharmacovigilance operations to ensure the consistency and accuracy of adverse event reporting in clinical studies including initial safety review of adverse events and medical review of clinical data, interaction with drug safety vendors, review of source documents, and preparation of documents for submission to regulatory authorities.

Responsibilities

• Participate in the operational aspects of adverse event reporting for all investigational products.
• Ensure consistency in the evaluation and assessment of adverse event reports and source documentation for completeness, accuracy and legibility.
• Ensure accuracy of MedDRA coding of adverse events‚Äô terms, medical history, and WHO Drug coding of concomitant medications.
• Support the clinical research team in the preparation/review of safety reports/data, e.g., Annual Reports, cumulative SAE reports, safety database reports, clinical study reports, MedWatch Reports, Tables/Listings/Figures, and other reports as deemed necessary.
• Participate in SAE Reconciliation activities.
• Supports the timely safety review of adverse events to determine seriousness, expectedness, reporter‚Äôs causality, and overall event resolution.
• Perform review of SAEs and provide causality assessment in collaboration with the drug safety physician/medical monitor.
• Provide oversight of end-to-end case processing and reviews.
• Interact on a regular basis with contract drug safety vendors and internal departments as applicable (i.e. data management, medical affairs, biostatistics, clinical operations etc.) to resolve safety-related issues.
• Review safety data output for accuracy and completeness prior to submission to internal and external sources.
• Maintain current knowledge of all applicable drug safety guidelines and regulations (FDA) and apply to safety tasks.
• Assists in preparation of safety documents for submission to regulatory authorities; in collaboration with the Regulatory Affairs Department.
• Author/Review clinical documents as applicable e.g. protocol, study plans etc.
• Ensure compliance with clinical protocol safety objectives, policies, processes, and procedures.
• Maintain knowledge of relevant disease and therapeutic areas for marketed drugs and drugs in development.
• Supports the Medical Affairs on adverse events seen with the use of marketed Products.
• Perform other safety/pharmacovigilance operations-related tasks as necessary.
• Knowledge and Experience with commercial products pharmacovigilance.
• Author/Review post-marketing safety reports (PSUR, PADER, PBRER etc).

Knowledge & Other Qualifications

• Degree in medical field (RN, PharmD or MD preferred), or significant experience in this line of work and a Master‚Äôs Degree.
• Minimum of 4 years of relevant work experience.
• Knowledge of medical and therapeutic terminology.
• Experience in medical monitoring and medical review.
• Experience in Standard Operating Procedures authorship.
• Experience in safety database(s).
• Working knowledge of ICH guidelines and other worldwide safety regulations.
• Demonstrated working knowledge of FDA regulations relevant to Patient Safety and adverse event reporting, including periodic safety reporting.
• Working knowledge of the principles and concepts associated with Patient Safety case-handling process, 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 of having 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 an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading.
• The worker is not substantially exposed to adverse environmental conditions.