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Associate Medial Director, Drug Safety Physician

Laboratory Corporation of America Holdings (Covance)

Sofia, Bulgaria

<p><span>Reporting to the Senior Medical Director, you will be largely responsible for the medical review of serious adverse events derived from clinical trials, in support of drug safety activities for clients. </span></p><p></p><ul><li><span>Responsible for medical review of serious adverse events and adverse events of special interest from Clinical Trials in support of safety activities for clients.</span></li><li><span>Reviews laboratory values, adverse events, coding dictionaries and data tables, listings and figures as needed to identify drug safety issues in collaboration with the project physician</span></li><li><p>When applicable, responsible for preparation and medical review of Aggregate Reports (Periodic Safety Update Reports – PSURs, Periodic Adverse Drug Experience Reports – PADERs) required by global regulatory agencies for review of safety information for assigned products, when authorized to perform this function on behalf of a client.</p></li><li><p>When applicable, responsible for signal detection and evaluation activities and preparation and submission of Ad Hoc Reports reviewing specific safety issues to the global regulatory agencies for assigned products, when authorized to perform this function on behalf of a client.</p></li><li><p>Participates in training opportunities to advance knowledge of pharmacovigilance and serves as a consultant on pharmacovigilance issues to the project physician</p></li><li><p>Provides medical/safety expertise to project teams, including communicating information regarding drug safety regulations and any changes that have occurred</p></li><li><p>Assists in the preparation of pharmacovigilance materials for investigator meetings</p></li><li><p>Assumes responsibility for medical and safety monitoring on assigned projects</p></li><li><p>Provides mentoring of and indirect supervision of Senior Drug Safety Associates, and Drug Safety Associates</p></li><li><p>Responsible for communicating status of projects and other activities to the Senior Medical Director (Lead) and others as appropriate.</p></li></ul><p></p><p><b>Experience: </b>Required for Associate Director level: (115)</p><p>At least 2 years of experience working either for a pharmaceutical company, health authority or a contract research organization in related fields such as QA, Regulatory Affairs, medical writing, PCS, TM or clinical medical monitoring</p><p></p><p><b><span><span>Education/Qualifications/Certifications</span> and Licenses:</span></b></p><ul><li><p><u>Required:</u> MD or DO with at least one year of postgraduate training or equivalent.</p></li><li><p><u>Preferred:</u> MD who has completed an accredited residency program or equivalent and is board-eligible or certified with at least 4 years experience with substantial knowledge of drug safety and the global regulations governing pharmacovigilance and risk management  </p></li></ul><p>  </p><p><b>Competencies: </b></p><p>Required: Strong communication (oral and written English) skills</p><p>Good interpersonal skills</p><p>Well organized</p><p>Ability to work independently and in teams</p><p>Good prioritization skills</p><p>Ability to adjust to changes in tasks as required</p><p>Ability  to provide leadership and guidance to indirect reports – Senior Drug Safety Associates and Drug Safety Associates</p><p>Ability to represent the company at client, industry and medical meetings</p><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: 2022-04-29

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