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Drug Safety Specialist (Thai/Bahasa/Indonesian speaker)

Laboratory Corporation of America Holdings (Covance)

Singapore, Singapore

<h2>Job Overview:</h2><ul><li><span style="font-size: 10pt; font-family: helvetica;">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: </span></li><li style="margin-left: 72.0pt;"><span style="font-size: 10pt; font-family: helvetica;">entry of safety data onto adverse event database(s) and tracking systems</span></li><li style="margin-left: 72.0pt;"><span style="font-size: 10pt; font-family: helvetica;">review of adverse events for completeness, accuracy and appropriateness for expedited reporting</span></li><li style="margin-left: 72.0pt;"><span style="font-size: 10pt; font-family: helvetica;">write patient narratives</span></li><li style="margin-left: 72.0pt;"><span style="font-size: 10pt; font-family: helvetica;">code adverse events accurately using MedDRA</span></li><li style="margin-left: 72.0pt;"><span style="font-size: 10pt; font-family: helvetica;">determine expectedness/listedness against appropriate label</span></li><li style="margin-left: 72.0pt;"><span style="font-size: 10pt; font-family: helvetica;">identifies clinically significant information missing from initial reports and ensures its collection</span></li><li style="margin-left: 72.0pt;"><span style="font-size: 10pt; font-family: helvetica;">ensure case receives appropriate medical review</span></li><li style="margin-left: 72.0pt;"><span style="font-size: 10pt; font-family: helvetica;">prepare follow-up correspondence consulting the medical staff accordingly.</span></li><li style="margin-left: 72.0pt;"><span style="font-size: 10pt; font-family: helvetica;">ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines</span></li><li style="margin-left: 72.0pt;"><span style="font-size: 10pt; font-family: helvetica;">reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines</span></li><li><span style="font-size: 10pt; font-family: helvetica;">Provide translation support from Thai or Bahasa/ Indonesian to English</span></li><li><span style="font-size: 10pt; font-family: helvetica;">Maintain a strong understanding of Covance’s safety database conventions or client specific database conventions, as appropriate.</span></li><li><span style="font-size: 10pt; font-family: helvetica;">Begin participating in signal detection and trend and pattern recognition activities, as appropriate.</span></li><li><span style="font-size: 10pt; font-family: helvetica;">Begin preparing timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events</span></li><li><span style="font-size: 10pt; font-family: helvetica;">Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs) and Periodic Safety Update Reports (PSURs).</span></li><li><span style="font-size: 10pt; font-family: helvetica;">Work with Data Management or client on reconciliation of safety databases.</span></li><li><span style="font-size: 10pt; font-family: helvetica;">Begin participating in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.</span></li><li><span style="font-size: 10pt; font-family: helvetica;">Support/train less experienced safety staff in all aspects of case-handling, adverse event reporting.</span></li><li><span style="font-size: 10pt; font-family: helvetica;">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.</span></li><li><span style="font-size: 10pt; font-family: helvetica;">Possess knowledge of other procedural documents, e.g., SOPs, etc. that impact Safety.</span></li><li><span style="font-size: 10pt; font-family: helvetica;">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.</span></li><li><span style="font-size: 10pt; font-family: helvetica;">Build and maintain good PSS relationships across functional units.</span></li><li><span style="font-size: 10pt; font-family: helvetica;">Demonstrate role-specific Competencies on a consistent basis.</span></li><li><span style="font-size: 10pt; font-family: helvetica;">Demonstrate company Values on a consistent basis.</span></li><li><span style="font-size: 10pt; font-family: helvetica;">Begin to develop a good knowledge of contract assumptions; identifying out of scope work.</span></li><li><span style="font-size: 10pt; font-family: helvetica;">Read and understand Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency.</span></li><li><span style="font-size: 10pt; font-family: helvetica;">Begin participating in Covance project teams and client meetings as appropriate.</span></li><li><span style="font-size: 10pt; font-family: helvetica;">Assist in the review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients.</span></li><li><span style="font-size: 10pt; font-family: helvetica;">Assist with the set-up of, and the provision of data to, Safety Committees/DSMBs.</span></li><li><span style="font-size: 10pt; font-family: helvetica;">Assist in the co-ordination of endpoint committees, as required.</span></li><li><span style="font-size: 10pt; font-family: helvetica;">Any other duties as assigned by management.</span></li></ul><h2>Education/Qualifications:</h2><ul><li style="margin-left: 0cm;"><span style="font-size: 10pt;">Non-degree + 4-5 yrs relevant experience (or 2 yrs safety experience)*</span></li><li style="margin-left: 0cm;"><span style="font-size: 10pt;">Associates Degree + 3-4 yrs relevant experience (or 1-2 yrs safety experience)*</span></li><li style="margin-left: 0cm;"><span style="font-size: 10pt;">Associate degree RN + 2-3 yrs relevant experience (or 1-2 yrs safety experience)*</span></li><li style="margin-left: 0cm;"><span style="font-size: 10pt;">BS/BA + 1-2 yrs relevant experience**</span></li><li style="margin-left: 0cm;"><span style="font-size: 10pt;">MS/MA + 0 yr relevant experience**</span></li><li style="margin-left: 0cm;"><span style="font-size: 10pt;">PharmD + 0 yrs relevant experience**</span></li><li>Fluency in Thai or Bahasa/ Indonesian and English both verbal and written communication in a business and operational environment</li></ul><p style="margin: 0px;"><span style="font-size: 10pt;">Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.</span></p><p style="margin: 0px;"><span style="font-size: 10pt;"> </span></p><p style="margin: 0px;"><span style="font-size: 10pt;">*Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.</span></p><p style="margin: 0px;"><span style="font-size: 10pt;"> </span></p><p style="margin: 0px;"><span style="font-size: 10pt;">**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.</span></p><h2>Experience:</h2><p style="margin: 0px;"> </p><ul><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">High degree of accuracy with attention to detail.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Functions as a team player.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Good Communication.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Knowledge of medical and drug terminology desirable.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Familiarity of Good Clinical Practice (GCP) related to clinical safety documentation.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Familiarity with ICH Guidelines</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Familiarity of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Familiarity of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Good written and verbal communication skills.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Ability to work independently with moderate supervision.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial<span style="font-family: 'Arial',sans-serif;">.</span></span></li></ul>

Job posted: 2022-01-11

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