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Safety Analysis Scientist

Laboratory Corporation of America Holdings (Covance)

Manila, Philippines

<p><span>The safety analysis scientist (SAS) is mainly responsible for core safety deliverables related to periodic and ad hoc aggregate reporting and safety monitoring of drug and vaccine products. The SAS will also support deliverables related to cross-functional or benefit-risk assessment teams, as required.</span></p><p></p><h2><span>Responsibilities</span>:</h2><ul><li><span>Perform aggregate analysis and case level review of medium to high complexity safety data, including data from clinical trials </span></li><li><span>Conduct literature and PV database searches</span></li><li><span>Organize and lead planning and strategy meetings, and perform project management activities for safety reports/deliverables.</span></li><li><span>Work closely with the safety physician and liaise with cross-functional stakeholders/teams </span></li><li><span>Author <span>and contribute to various safety reports (or part of such reports) per approved strategy; perform quality review of such reports, as required</span></span></li><li><span>Participate, present analyses, and contribute to discussions in safety/benefit-risk review meetings</span><span>.</span></li></ul><p></p><h2><span>Education / Qualifications</span></h2><ul><li><span>Bachelor's degree in Health or Biomedical Science (6-8 years industry experience or equivalent)</span></li><li><span>Advanced Degree preferred in Health or Biomedical Science (4-6 years industry experience or equivalent)</span></li></ul><p></p><h2><span>Experience</span></h2><ul><li><span>Authoring and review of periodic and adhoc safety reports (more than 5 years of experience required in safety or clinical documents such as PSURs, DSURs, ACOs, Clinical overviews, Clinical study reports or summaries); experience in signal detection/safety surveillance, risk management, and preparing responses to health authority requests preferred</span></li><li><span>Experience in safety analysis and writing for biologics, advanced therapy products or drug/vaccine products in development, preferred</span></li></ul><p></p><p><b>Labcorp is proud to be an Equal Opportunity Employer:</b></p><p></p><p>As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.</p><p></p><p>For <span>more information about how we collect and store your personal data, please see our </span><span><a href="https://www.labcorp.com/hipaa-privacy/web-privacy-policy" target="_blank">Privacy Statement</a></span><a href="https://www.labcorp.com/hipaa-privacy/web-privacy-policy" target="_blank"><span>.</span></a><span> </span></p>

Job posted: 2022-04-13

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