This position is responsible for participating in the collection, safety review, processing and reporting of adverse event data in compliance with applicable FDA and global regulations and Inovio Pharmaceuticals standard operating procedures and guidelines. The Drug Safety Associate/Specialist will ensure accurate data entry of identified adverse event information and the timely processing and reporting of adverse events in alignment with regulatory requirements.
The Drug Safety Associate/Specialist is responsible for supporting Inovio physicians and scientists in activities related to safety review and analysis of investigational or marketed products and devices.
Essential job functions and duties
Responsibility for all operational functions that support clinical trial drug safety and pharmacovigilance practices, including, but not limited to:
Maintain clinical trial safety data reporting processes and aggregate analysis strategies to ensure compliance with applicable regulatory requirements.
Working with vendors, as required, to ensure processes and strategies are maintained, internal and external timelines are met, potential issues are communicated and resolution is achieved in a timely manner
Contribute clinical safety expertise to the content of clinical study-related documents to ensure they reflect responsibilities and requirements involved in the collection, evaluation and reporting of safety data from clinical studies
Manage activities in specific projects as assigned. These projects may include, but are not limited to, managing compliance with safety data exchange agreement (SDEA) contracts, and contributing to the development and maintenance of risk management plans (RMPs), risk evaluation and mitigation strategies (REMS), and/or benefit-risk assessments.
Create or update Standard Operating Procedures/Work Instructions, as directed.
Support inspection readiness and audits as required
BS/BA in a health or biological science discipline (or licensed certification) and clinical experience as a health care professional
4-6 years relevant experience in clinical safety/pharmacovigilance with a concentration of experience in clinical safety activities associated with the conduct of clinical trials