Location: Wilmington, NC
Start date: 10/01
Category: Full Time
Roles & Responsibilities:
- Actively participates in the case initiation process (case triage) and case data inputting/data entry as more complete SAE information becomes available.
- Manage and maintain Global safety mailbox.
- May participate in the case narrative generation, review and refinement process depending upon level of experience.
- Conducts several rounds of query and response (back to site) under the guidance of Medical reviewers to gain complete and accurate case information.
- Navigates Safety Database including the advancing of cases within the workflow and understanding and conducting of various medical coding applications.
- Processes all field and narrative case data entry.
- Processes all Adverse Effects (AE), medical history and con meds coding.
- Transfers case to Regulatory Affairs for Submission (if SUSAR) or Final Closure of Case in global database (if not an expedited report).
- Ensures that all international regulations are followed regarding pharmacovigilance procedures.
- Perform quality control activities including the review of source documents and case data to verify accuracy and consistency as well as to ensure compliance with timelines and quality standards
- Participates as a cross functional team member of Study Execution Teams.
- Participates in Serious Adverse Event (SAE) Reconciliation activities with the SAE information in the clinical trial database.
- Performs periodic Global Safety Database searches to support inquiries from stakeholders as required.
- May assists in the creation of ad hoc safety reports for submission to relevant stakeholders both inside and external.
- Reviews and may be responsible for authoring Standard Operating Procedures (SOPs) and Work Practice Instructions.
- Reviews all cases for completeness and accuracy of data versus available source documents.
- Ensures that in all received and created documentation, that patient privacy and confidentiality of identity be maintained and recommends steps that should be taken to avoid or mitigate breaches.
Education & Experience:
- Bachelor’s degree in pharmacy / related field
- 1 – 2 years of experience in drug safety/regulatory affairs or pharmaceutical domain is required
- Must be methodical, compliant to processes yet flexible when needed
- Independent yet able to work cohesively with a team