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Drug Safety Associate II (Thai/Bahasa/Indonesian speaker)

Laboratory Corporation of America Holdings (Covance)

Singapore, Singapore

<h2>Job Overview:</h2><ul><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Assist in or complete per the Safety Management Plan (SMP) the processing of all adverse event reports from any source.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt; font-family: helvetica;">Provide translation support from Thai or Bahasa/ Indonesian to English</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Assist in producing queries of safety data for clients as appropriate.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Assist in the generation and maintenance of the PSS metrics.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Assist Data Management or clients on reconciliation of safety databases.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Provide input for monthly status reports.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Maintains a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Possess knowledge of other procedural documents, e.g., SOPs, and how they impact safety.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Build and maintain good PSS relationships across functional units.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Demonstrate role-specific Core Competencies on a consistent basis.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Demonstrate company Values on a consistent basis.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Assist in the preparation of client meetings and liaise with clients where appropriate.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Assist with the set-up of, and the provision of data to, Safety Committees/DSMBs.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Any other duties as assigned by management.</span></li></ul><h2>Education/Qualifications:</h2><ul><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Non-degree + 3-4 yrs relevant experience** (or 1 yr safety experience)*</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Associates Degree + 2-3 yrs relevant experience** (or 1 yr safety experience)*</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Associate degree RN + 1-2 yrs relevant experience**</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">BS/BA + 0 yrs</span></li><li style="margin-left: 18.0pt;">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 (but not necessary) 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><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;">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 with knowledge of MS Office and Windows application would be beneficial.</span></li></ul>

Job posted: 2022-01-11

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