Supernus Pharmaceuticals, Inc. · 2 months ago
Senior Manager, Drug Safety
Rockville, MD
Full-time
Onsite
Mid, Senior Level
$130K/yr - $155K/yr
4+ years expSupernus Pharmaceuticals, Inc. is seeking a Senior Manager of Drug Safety to support drug safety and pharmacovigilance operations. The role involves ensuring the consistency and accuracy of adverse event reporting in clinical studies and interacting with drug safety vendors to prepare documents for regulatory submission.
BiotechnologyHealth CarePharmaceutical
No H1B
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’ 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’s 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)
Qualification
Required
Degree in medical field (RN, PharmD or MD preferred), or significant experience in this line of work and a Master's 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
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
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
Benefits
Opportunity to participate in employee stock purchase programs
Performance-based bonus programs
Company
Supernus Pharmaceuticals, Inc.
We are a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$689.5MKey Investors
UBSNew Enterprise Associates
2023-02-14Post Ipo Debt· $150M
2018-03-13Post Ipo Debt· $350M
2013-04-24Post Ipo Debt· $90M
Leadership Team
J
Jack A. Khattar
President & CEO
F
Frank Mottola
Chief Technical Operations Officer
Recent News
2025-12-08
Company data provided by crunchbase