Drug Safety Associate
|ポジション名||Drug Safety Associate|
・Manage the receipt, processing and quality review of expedited safety reports (ESRs) to Japan PMDA. This includes, but is not limited to
・maintenance of adverse event tracking systems
・set-up and maintenance of project files, core process files and central safety files
・contact with Regulatory Authorities, project teams and with clients to support safety reporting activities
・Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes.
・Maintain a strong understanding of our company safety database conventions or client specific database conventions, as appropriate.
・Begin participating in signal detection and trend and pattern recognition activities, as appropriate.
・Begin preparing timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events
・Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs) and Periodic Safety Update Reports (PSURs).
・Work with Data Management or client on reconciliation of safety databases.
・Begin participating in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.
・Support/train less experienced safety staff in all aspects of case-handling, adverse event reporting.
・Maintains a comprehensive understanding of our company Safety’s Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
・Possess knowledge of other procedural documents, e.g., SOPs, etc. that impact Safety.
・Ensure compliant safety reporting in accordance with US and international reporting regulations, SOPs and safety processing guidelines set forth by departmental management team and the client.
・Build and maintain good PSS relationships across functional units.
・Demonstrate role-specific Competencies on a consistent basis.
・Demonstrate company Values on a consistent basis.
・Begin to develop a good knowledge of contract assumptions; identifying out of scope work.
・Read and understand Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency.
・Assist in the review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients.
・Assist with the set-up of, and the provision of data to, Safety Committees/DSMBs.
・Assist in the co-ordination of endpoint committees, as required.
・Any other duties as assigned by management.
Non-degree + 4-5 yrs relevant experience (or 2 yrs safety experience)*
Associates Degree + 3-4 yrs relevant experience (or 1-2 yrs safety experience)*
Associate degree RN + 2-3 yrs relevant experience (or 1-2 yrs safety experience)*
BS/BA + 1-2 yrs relevant experience**
MS/MA + 0 yr relevant experience**
PharmD + 0 yrs relevant experience**
Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.
*Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
**Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.