POSITION OBJECTIVE: Supports the Pharmacovigilance team to maintain the Global Safety Mailbox, Case Book-in, Data Entry and documentation on all serious adverse side effect (SAE) cases related to clinical studies.
Essential Job Functions/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 to Athenex.
- 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.
Required Education & Qualifications
- Bachelor degree in life sciences. Health care professional (pharmacy, nursing or equivalent) is strongly preferred.
- Minimum of 2 to 3 years of experience with product safety in pharmaceutical, biotech or clinical research organization, preferably oncology based.
- Experience with drug safety databases, case processing and MedDRA coding concepts
- Attention to quality focusing on details with enthusiasm toward ways to improve processes
- Proficient in business related software suites.
- Written and oral communication skills commensurate with a member of a pharmacovigilance operations department.
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.