PV Compliance 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><ul><li>To provide support in the establishment, maintenance and development of the PV compliance monitoring <span>system.</span></li><li>Review and data entry of metrics in compliance tracking systems and <span>tools.</span></li><li>Metric collection and preparation of the regular management <span>reports</span></li></ul><p></p><p><b><span>Core<span> </span>Job<span> Responsibilities:</span></span></b></p><p><span><span>•<span>      </span></span></span><span>Collection of compliance data within<span> </span>GPV<span> </span>and other stakeholders<span> </span>of the<span> </span>PV- and<span> </span>medical device vigilance system within the agreed <span>timelines.</span></span></p><p><span><span>•<span>      </span></span></span><span>Maintains<span> </span>and<span> </span>further<span> </span>develops<span> </span>the<span> </span>compliance<span> </span>monitoring<span> </span>system<span> </span>and<span> </span>compliance<span> </span>tracking databases<span> </span>with<span> </span>the<span> </span>support<span> </span>of<span> </span><span>IT.</span></span></p><p><span><span>•<span>      </span></span></span><span>Collates<span> </span>metrics<span> </span>and<span> </span>drafts<span> </span>compliance<span> </span>overviews<span> </span>(Key<span> </span>Performance<span> </span>Indicators<span> </span>(KPls),<span> </span>PV<span> </span>Compliance<span> </span><span>Summaries).</span></span></p><p><span><span>•<span>      </span></span></span><span>Requests<span> </span>non-compliance<span> </span>information </span><i><span>I<span> </span></span></i><span>corrective/preventive<span> </span>actions<span> </span>when<span> </span>not<span> </span>provided<span> </span>by<span> </span>the non-compliant<span> </span><span>party.</span></span></p><p><span><span>•<span>      </span></span></span><span>Performs<span> </span>regular<span> </span>CAPA<span> </span>reviews<span> </span>and<span> </span>follow-up<span> </span>with<span> </span>responsible<span> </span>organization<span> </span>in<span> </span>case<span> </span>of<span> </span>quality<span> </span><span>issues</span></span></p><p><span><span>•<span>      </span></span></span><span>Manages the tracking of non-compliance<span> </span>information/ corrective/preventive actions and generates periodic reviews of compliance data and trending of root causes.</span></p><p><span><span>•<span>      </span></span></span><span>Initiates investigations<span> </span>of non-compliance<span> </span>occurrences and documents investigation findings and proposes solutions according to the process defined within GPV.</span></p><p><span><span>•<span>      </span></span></span><span>Assists<span> </span>in<span> </span>the<span> </span>liaison<span> </span>with<span> </span>relevant<span> </span>interfaces<span> </span>to ensure<span> </span>compliance<span> </span>is<span> </span>monitored<span> </span>for<span> </span>GPV<span> </span>through<span> </span>relevant<span> </span><span>KPls.</span></span></p><p><span><span>•<span>      </span></span></span><span>Participates in training of relevant personnel on Compliance relevant topics<span> </span>(e.g. Affiliate tracking of submissions, CAPA Management <span>Tool).</span></span></p><p><span><span>•<span>      </span></span></span><span>Escalates<span> </span>to the<span> </span>Head<span> </span>PV<span> </span>System<span> </span>&amp;<span> </span>Compliance,<span> </span>and<span> </span>if<span> </span>applicable<span> </span>the<span> </span>QPPV,<span> </span>any<span> </span>serious<span> </span>compliance<span> </span>or<span> </span>performance<span> </span>issues<span> </span>in <span>order</span></span></p><p><span>to<span> </span>take<span> </span>immediate<span> </span>action<span> </span></span><span>(corrective<span> </span></span><span>-<span> </span>or<span> </span>preventative<span> </span><span>action).</span></span></p><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>