Senior Specialist PSS

<h2>Job Overview:</h2><p style="margin: 0px;">Labcorp are recruiting a Senior Specialist PSS to join our team in Bulgaria.</p><p style="margin: 0px;"> </p><p style="margin: 0px;">Role responsibilities:</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><p style="margin: 0px;">Entry of safety data onto adverse event database(s) and tracking systems.</p><p style="margin: 0px;">Review of adverse events for completeness, accuracy and appropriateness for expedited reporting.</p><p style="margin: 0px;">Write patient narratives.</p><p style="margin: 0px;">Code adverse events accurately using MedDRA.</p><p style="margin: 0px;">Determine expectedness/listedness against appropriate label.</p><p style="margin: 0px;">Identifies clinically significant information missing from initial reports and ensures its collection.</p><p style="margin: 0px;">Ensure case receives appropriate medical review.</p><p style="margin: 0px;">Prepare follow-up correspondence consulting the medical staff accordingly.</p><p style="margin: 0px;">Ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines.</p><p style="margin: 0px;">Reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines.</p><p style="margin: 0px;">Provide independent QC of AE reports for other members of the group.</p><p style="margin: 0px;">May execute routine quality review of AE reports and aggregate reports for other members of the group ensuring that case processing and data quality meet global regulatory compliance needs including audit support.</p><p style="margin: 0px;">Prepares timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs), Annual IND reports, European Annual Safety Reports (ASRs), Development Safety Update Report (DSUR), Periodic Reports (PRs) line listings, and aggregate reports.</p><p style="margin: 0px;">Monitor workflow for assigned studies/programs to ensure all deadlines are met.</p><p style="margin: 0px;">Support/train less experienced safety staff in all aspects of case-handling, adverse event reporting and other work, as needed.</p><p style="margin: 0px;">Responsible for making decisions regarding adverse event reporting within the guidelines of each specific project.</p><p style="margin: 0px;">Any other duties as assigned by management.</p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">#LI-NC1 EMEA</span></p><h2>Education/Qualifications:</h2><p style="margin: 0px;">Required:</p><p style="margin: 0px;"><span style="font-family: 'Segoe UI Symbol',sans-serif;">♦</span> Non-degree + 5-6 yrs safety experience*</p><p style="margin: 0px;"><span style="font-family: 'Segoe UI Symbol',sans-serif;">♦</span> Associate degree + 4-5 yrs safety experience*</p><p style="margin: 0px;"><span style="font-family: 'Segoe UI Symbol',sans-serif;">♦</span> Associate degree RN + 4-5 yrs safety experience*</p><p style="margin: 0px;"><span style="font-family: 'Segoe UI Symbol',sans-serif;">♦</span> BS/BA + 3-4 yrs safety experience*</p><p style="margin: 0px;"><span style="font-family: 'Segoe UI Symbol',sans-serif;">♦</span> MS/MA + 2-3 yrs relevant experience** (1-2 yrs safety experience)</p><p style="margin: 0px;"><span style="font-family: 'Segoe UI Symbol',sans-serif;">♦</span> PharmD + 1-2 yrs relevant experience** (1 yr safety experience)</p><p style="margin: 0px;"> </p><p style="margin: 0px;"> </p><p style="margin: 0px;">For PharmD, a one-year residency of fellowship can be considered relevant experience.</p><p style="margin: 0px;">Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy,</p><p style="margin: 0px;">Nursing, Life Sciences, and Chemistry.</p><h2>Experience:</h2><p style="margin: 0px;">Candidates must have safety experience including actual experience processing AE/SAE reports, generating narratives, queries, QC of narratives and QC of SAEs, working within safety databases, and experience with regulatory submissions.</p><p style="margin: 0px;">Must have good verbal, written and presentation skills.</p><p style="margin: 0px;">Must be able to communicate effectively in the English language.</p><p style="margin: 0px;">Ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level.</p><p style="margin: 0px;">High degree of accuracy with attention to detail.</p><p style="margin: 0px;">Functions as a team player.</p><p style="margin: 0px;">Ability to present and share useful business information across departments and functions.</p><p style="margin: 0px;">Ability to anticipate and identify problems and take appropriate action to correct.</p><p style="margin: 0px;">Knowledge of medical and drug terminology.</p><p style="margin: 0px;">Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation.</p><p style="margin: 0px;">Knowledge of ICH Guidelines.</p><p style="margin: 0px;">Knowledge of Medical Device reporting desirable.</p><p style="margin: 0px;">Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.</p><p style="margin: 0px;">Good knowledge and understanding of industry and R&D processes and objectives.</p><p style="margin: 0px;">Ability to work independently with minimal supervision.</p><p style="margin: 0px;">Good keyboard skills, knowledge of MS office and Windows.</p>