Assoc I PSS

<h2>Job Overview:</h2><p style="margin: 0px;"> </p><p style="margin: 0px;">♦ collection all data on call center and documenting them acording to the legislation, WI,etc <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 />♦ Any other duties as assigned by management.</p><p style="margin: 0px;"> </p><p style="margin: 0px;"> </p><h2>Education/Qualifications:</h2><p style="margin: 0px;">Required:</p><p style="margin: 0px;">♦ great level of german (C1 level) preferable with certification and professional english level<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 /><br /></p><h2>Experience:</h2><p style="margin: 0px;">Required:</p><p style="margin: 0px;"> </p><p style="margin: 0px;">♦ HCP with great level of german and english level<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>