PV System Specialist

<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>JOB DESCRIPTION:</b></h2><p><b>Primary Job <span>Function:</span></b></p><p>The position holder ensures compliant roll-out of PV training to all global, regional and local PV personnel through maintaining up to date the PV training matrices for GPV Headquarter and Affiliate PV staff and its implementation and tracking in the electronic Learning Management System ISOtrain.</p><p><b>Core Job <span>Responsibilities:</span></b></p><p></p><ul><li>Independently liaises with relevant PV and non-PV stakeholders (e.g., Clinical Department, Medical Affairs, Regulatory Affairs within l&amp;D Operational Excellence and non l&amp;D functions, as applicable):<ul><li>to ensure PV training is rolled out to all EPD <span>employees.</span></li><li>to ensure that the PV training matrices for all PV personnel is up to date and <span>compliant.</span></li><li>to ensure PV training requirements for all global and regional EPD non-PV employees is communicated accordingly.</li></ul></li><li>Assigns training modules and retrieve training records in <span>ISOtrain.</span></li><li>Ensures that local and global procedures related to GPV processes are established and kept <span>current.</span></li><li>Establishes and manages GPV procedures in the electronic Document Management System (eDMS) and departmental controlled forms.</li><li>Reviews procedural changes in interface EPD procedures for impact and coordinates GPV responses and initiates Implementation Reviews for PV.</li><li>Business Administrator role for <span>eDMS.</span></li><li>Site System Administrator back up role for Hanover <span>Site.</span></li><li>Supports GPV users of the eDMS in case of issues via the OMS support process with the <span>vendor.</span></li><li>Assists with authoring, editing, review, approval, training, import and export of new and existing <span>documents.</span></li><li>Maintains a process for periodic review of <span>documents.</span></li><li>Supports processes for maintenance of the Pharmacovigilance System Master File (PSMF), according to Good Pharmacovigilance Practice Module II.</li><li>Supports internal and 3rd party audits and health authority <span>inspections.</span></li><li>Tracks and reports on a regular basis KPls concerning PV system to the PV Compliance <span>function.</span></li><li>Oversight on GPV documents and their archive <span>location(s).</span></li><li>Act as administrator and coordinator of the GPV <span>Sharepoint.</span></li><li>Participates in a variety of GPV project teams to assure PV system compliance with international <span>regulations.</span></li><li>Participates in l&amp;D wide training projects to ensure alignment of training processes throughout all l&amp;D departments.</li><li><span>Is</span> <span>PV</span> <span>representative</span> <span>in</span> <span>EPD</span> <span>Training Community.</span></li></ul><p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><p><b>The base pay for this position is </b></p>N/A<p style="text-align:left"><span>In specific locations, the pay range may vary from the range posted.</span></p><p style="text-align:inherit">     </p><h2><b>JOB FAMILY:</b></h2>Product Development<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>DIVISION:</b></h2>EPD Established Pharma<p style="text-align:inherit">&nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</p><h2><b>LOCATION:</b></h2>India &gt; Mumbai : BKC Building<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>ADDITIONAL LOCATIONS:</b></h2><p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>WORK SHIFT:</b></h2>Standard<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>TRAVEL:</b></h2>Not specified<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>MEDICAL SURVEILLANCE:</b></h2>Not Applicable<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>SIGNIFICANT WORK ACTIVITIES:</b></h2>Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><p style="text-align:inherit">     </p><p style="text-align:inherit">     </p>