국가임상시험지원재단

Sr/Drug Safety Associate (PV Specialist)


Responsibilities / Duties

Sr/Assoc Drug Safety will Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to.

? entry of safety data onto adverse event database(s) and tracking systems
? review of adverse events for completeness, accuracy and appropriateness for expedited reporting
? write patient narratives
? code adverse events accurately using MedDRA
? determine expectedness/listedness against appropriate label
? identifies clinically significant information missing from initial reports and ensures its collection
? ensure case receives appropriate medical review
? prepare follow-up correspondence consulting the medical staff accordingly.
? ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines
? reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines
? Support electronic submission of safety reports to Korea MFDS and act as point of contact for safety related question to MFDS
? Maintain a strong understanding of Covance’s 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 Covance 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 PV&DSS 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.
? Begin participating in Covance project teams and client meetings as appropriate.
? 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.

Education / Qualifications

- Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions
- At least 1.5 year of drug safety exp. in clinical
- Good English communication

채용 담당자 : Natalie.Zheng@covance.com(채용 관련 문의나 이력서는 이메일로 부탁 드립니다)