Specialist I Patient Safety, Romania

<h2>Job Overview:</h2><p style="margin: 0px;">Covance is looking for a Specialist I Patient Safety with C1 level of German language and working level of English language.</p><p style="margin: 0px;"> </p><p style="margin: 0px;">Please note that you would be working in shifts (<span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">in the mornings, then in afternoons 2 week rotation).</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;">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:</p><ul><li>entry of safety data onto adverse event database(s) and tracking systems</li><li>review of adverse events for completeness, accuracy and appropriateness for expedited reporting</li><li>write patient narratives</li><li>code adverse events accurately using MedDRA</li><li>determine expectedness/listedness against appropriate label</li><li>identifies clinically significant information missing from initial reports and ensures its collection</li><li>ensure case receives appropriate medical review</li><li>prepare follow-up correspondence consulting the medical staff accordingly.</li><li>ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines</li><li>reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines</li></ul><p style="margin: 0px;"> </p><ul><li>Maintain a strong understanding of Covance’s safety database conventions or client specific database conventions, as appropriate.</li><li>Begin participating in signal detection and trend and pattern recognition activities, as appropriate.</li><li>Begin preparing timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events</li><li>Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs) and Periodic Safety Update Reports (PSURs).</li><li>Work with Data Management or client on reconciliation of safety databases.</li><li>Begin participating in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.</li><li>Support/train less experienced safety staff in all aspects of case-handling, adverse event reporting.</li><li>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.</li><li>Possess knowledge of other procedural documents, e.g., SOPs, etc. that impact Safety.</li><li>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.</li><li>Build and maintain good PSS relationships across functional units.</li><li>Demonstrate role-specific Competencies on a consistent basis.</li><li>Demonstrate company Values on a consistent basis.</li><li>Begin to develop a good knowledge of contract assumptions; identifying out of scope work.</li><li>Read and understand Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency.</li><li>Begin participating in Covance project teams and client meetings as appropriate.</li><li>Assist in the review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients.</li><li>Assist with the set-up of, and the provision of data to, Safety Committees/DSMBs.</li><li>Assist in the co-ordination of endpoint committees, as required.</li><li>Any other duties as assigned by management.</li></ul><h2>Education/Qualifications:</h2><p style="margin: 0px;">Required:</p><p style="margin: 0px;">♦ German C1 language (certificate C1 for German language)</p><p style="margin: 0px;">♦ English C1/B2 language</p><p style="margin: 0px;"><br />Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.</p><h2>Experience:</h2><p style="margin: 0px;">Required:<br />♦ High degree of accuracy with attention to detail.<br />♦ Functions as a team player.<br />♦ Good Communication.<br />♦ Knowledge of medical and drug terminology desirable.<br />♦ Familiarity of Good Clinical Practice (GCP) related to clinical safety documentation.<br />♦ Familiarity with ICH Guidelines<br />♦ Familiarity of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.<br />♦ Familiarity of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.<br />♦ Good written and verbal communication skills.<br />♦ Ability to work independently with moderate supervision.<br />♦ Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.</p>