Senior Project Lead Patient Safety Solutions

<h2>Job Overview:</h2><ul><li style="color: #000000;"><span style="font-size: 10pt; font-family: verdana, geneva;">Oversee the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial for assigned projects. </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Ensure compliant safety reporting in accordance with international reporting regulations, SOPs and safety processing guidelines, for assigned projects.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Maintain a strong understanding of Labcorp's safety database conventions or client-specific database conventions, as appropriate.</span></li></ul><ul><li style="color: #000000;"><span style="font-size: 10pt; font-family: verdana, geneva;">Supports preparation of pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs), Annual IND reports, Development Safety Update Report (DSUR) Periodic Safety Reports (PSRs) line listings, and aggregate reports.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Actively participate in and demonstrate leadership on projects which enhance team and/or division performance. This will include acting as safety lead for projects at global or regional level, ensuring communication and process harmonization.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Work with internal or external partners for reconciliation of safety databases, if appropriate.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">May support workflow monitoring for assigned studies/programs to ensure deadlines are met.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Draft/modify and deliver safety presentations as required, to external and internal stakeholders.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Maintains a comprehensive understanding of Labcorp's departmental Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Possess knowledge of other procedural documents, e.g. SOPs, etc. that impact department.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Assist in the development of departmental Work Instructions (WI) and Standard Operating Procedures (SOPs), as appropriate.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">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 style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Participate in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics/data are provided.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Build and maintain good departmental relationships across functional units.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Engage in preparation of Safety Management Plans (SMPs), Reconciliation Plans and other safety-specific plans under supervision.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Engage in preparation of study specific job aids, instructions, trainings and templates. </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Support systems set up during study start up and ongoing maintenance. </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Engage in taking decisions regarding adverse event reporting within the guidelines of each assigned project.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Assist departmental management/safety leads with project financial management and identifying out of scope work.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Engage in project specific functional management for assigned projects (access requests, training assignment etc.)</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Assist in TMF management activities as required.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Actively participate in project team and client meetings and liaise with clients, where appropriate.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Prepare and/or participate in internal, client or regulatory audits, and support other functional safety leads in audit preparation.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Assist with the provision of data to Safety Committees/DSMBs.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Demonstrate role-specific competencies on a consistent basis.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Demonstrate company values on a consistent basis.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Any other duties as assigned by safety lead or management.  </span></li></ul><h2>Education/Qualifications:</h2><p style="margin: 0cm 0cm 0pt;"> </p><p style="margin: 0cm 0cm 0pt;"><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: 0cm 0cm 0pt;"><span style="font-size: 10pt;"> </span></p><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 10pt;">*Safety experience includes actual operational experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.</span></p><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 10pt;"> </span></p><p style="margin: 0cm 0cm 0pt;"><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, Project Management or Quality Assurance.</span></p><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 11pt;"> </span></p><h2>Experience:</h2><h2 style="margin: 0cm 0cm 0pt;"> </h2><ul><li style="color: #000000;"><span style="font-size: 10pt; font-family: verdana, geneva;">6+ years of experience in drug safety and project management</span></li><li style="color: #000000;"><span style="font-size: 10pt; font-family: verdana, geneva;">Strong verbal, written and presentation skills.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Good communication and organizational skills.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">High degree of accuracy with attention to detail.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Functions as a team player.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Ability to present and share useful business information across departments and functions.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Ability to anticipate and identify problems and inform supervisor, support in taking appropriate action to correct.</span></li></ul><ul><li style="color: #000000;"><span style="font-size: 10pt; font-family: verdana, geneva;">Knowledge of medical and drug terminology </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Knowledge of ICH Guidelines</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Knowledge of Medical Device reporting desirable</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Knowledge of worldwide regulatory requirements and reporting of adverse event for investigational products.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Thorough knowledge and understanding of industry and R&D processes and objectives.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: verdana, geneva;">Strong skills using MS office required.</span></li></ul>