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Drug Safety Associate

Job summary

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:

  1. receipt of individual case safety reports and assessment of criteria to determine regulatory reporting requirements
  2. development of a concise narrative summary to accurately reflect the relevant clinical trial and medical information provided
  3. interaction with physicians and scientists for evaluation and completion of cases
  4. preparing individual cases for submission to regulatory authorities, as required
  5. review of aggregate data to support management of safety signals and the ongoing assessment of benefit-risk

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

Essential requirements

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

  • Expertise in clinical safety and pharmacovigilance processes and requirements and a firm understanding of FDA, ICH, EMA and GCP regulations. Experience with investigational and marketed medical devices is preferred
  • Experience in data entry using safety database applications and coding of terms using MedDRA
  • The ability to accurately record and represent relevant information from medical and diagnostic reports and prepare concise narrative summaries of safety information. Specific experience in cancer and infectious diseases would be highly desirable
  • Experience with preparation of investigational and post-marketing regulatory reports, including aggregate safety reports
  • Experience in the detection, evaluation, and management of safety signals
  • The ability to work independently across multiple projects and work collaboratively with other team members and colleagues across disciplines
  • The ability to follow established processes and the flexibility to adopt new practices and priorities as required
  • Proficiency in standard desktop software programs (Word, Excel, Outlook)
  • Minimum Travel required (<5%)
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