Assistant I PSS (Patient Safety)

<p>Due to continuous growth, the Patient Safety Solutions (PSS) team is looking to hire an Assistant I PSS. He or she will be responsible for assisting with the smooth running of the PSS Department to ensure all adverse events are processed to the required standard and submitted to the client and the regulatory agencies (if required) within the agreed upon timelines.</p><p><br /><b>Duties and Responsibilities:</b><br /><br />♦ Assist in or complete per the Safety Management Plan (SMP) the processing of all adverse event reports from any source.<br />♦ Assist in producing queries of safety data for clients as appropriate.<br />♦ Assist in the generation and maintenance of the PSS metrics.<br />♦ Assist Data Management or clients on reconciliation of safety databases.<br />♦ Provide input for monthly status reports.<br />♦ Maintains a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.<br />♦ Possess knowledge of other procedural documents, e.g., SOPs, and how they impact safety.<br />♦ Build and maintain good PSS relationships across functional units.<br />♦ Demonstrate role-specific Core Competencies on a consistent basis.<br />♦ Demonstrate company Values on a consistent basis.<br />♦ Assist in the preparation of client meetings and liaise with clients where appropriate.<br />♦ Assist with the set-up of, and the provision of data to, Safety Committees/DSMBs.<br /><br /><b>Language Skills Required:</b><br />♦ Speaking: Fluency in English and local language plus either Italian, German, French, Greek, Swedish or Dutch.<br />♦ Writing/Reading: English and local language as well as either of the above.</p><p></p><p><b>Experience Required:</b><br />♦ High degree of accuracy with attention to detail.<br />♦ Functions as a team player.<br />♦ Good communication.<br />♦ Good written and verbal communication skills.<br />♦ Ability to work independently with moderate supervision.<br />♦ Good keyboard skills with knowledge of MS Office and Windows application would be beneficial.</p><p><br /><b>Education/Qualifications/Certifications and Licenses</b><br />♦ Non-degree + 3 yrs relevant experience** (or 1 yr safety experience) *<br />♦ Associates Degree + 2 yrs relevant experience** (or 1 yr safety experience) *<br />♦ Associate degree RN + 1 yr relevant experience**<br />♦ BS/BA + 0 yrs<br />Degree preferred (but not necessary) to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.<br />*Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.<br />**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, or Quality Assurance.</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>