<ul><li>Responsible for development and maintenance of PV Safety Data Exchange Agreement (SDEA) of different clients.</li><li>Responsible for effective compliance of PV system in respect to SDEA Management.</li><li>Responsible for coordinating with different stakeholders on an urgent basis related to Pharmacovigilance activities &amp; queries.</li><li>To do the monthly reconciliation with the Licensing Partners.</li><li>Responsible for identifying the importance of SDEA with different stakeholders.</li><li>Responsible for identifying the gap among all SDEAs and need for updating the SDEA.</li><li>To assist the internal and external audits/ inspections.</li><li>To impart Pharmacovigilance training business partners related to PV procedures and regulatory obligations.</li><li>To evaluate potential medically relevant information with market complaints.</li><li>Any other additional responsibility may be assigned from time to time by management.</li></ul>

Safety Data Exchange Agreement ( Pharmacovigilance )