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                    <RecuiterJobNumber><![CDATA[11008]]></RecuiterJobNumber>
                    <title><![CDATA[Urgent opening for Executive-Pharmacovigilance / RA at Navi Mumbai Location]]></title>
                    <link><![CDATA[https://boyenhaddin.com/job/urgent-opening-for-executive-pharmacovigilance-ra-at-navi-mumbai-location/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=urgent-opening-for-executive-pharmacovigilance-ra-at-navi-mumbai-location]]></link>
                    <PostDate>Sat, 01 Aug 2020 06:40:46 +0000</PostDate>
                    <expiryDate>Sun, 21 May 2028 12:26:01 +0000</expiryDate>
                                            <applicationDeadline>Tue, 21 May 2024 12:25:52 +0000</applicationDeadline>
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                                        <employer><![CDATA[Boyen Haddin Consulting &#038; technology Pvt. Ltd.]]></employer>
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                                            <sector><![CDATA[Pharma, Biotech, Clinical Research]]></sector>
                                            <excerpt><![CDATA[<p>Position: &#8211; Executive-Pharmacovigilance / RA Location: Taloja, Navi Mumbai Experience: 2+ years Required skills:  · Pharmacovigilance knowledge · Knowledge of CDSCO documentation · Submitting documents on Sugam Portal · Complaint handling along with PV Job Description:  The position will be an Executive level. Main focus of the candidate will be handling Pharmacovigilance activity along with...</p>
The post <a href="https://boyenhaddin.com/job/urgent-opening-for-executive-pharmacovigilance-ra-at-navi-mumbai-location/">Urgent opening for Executive-Pharmacovigilance / RA at Navi Mumbai Location</a> first appeared on <a href="https://boyenhaddin.com">Boyen Haddin</a>.]]></excerpt>
                    <description><![CDATA[<div>Position: &#8211; Executive-Pharmacovigilance / RA</div>
<div>Location: Taloja, Navi Mumbai</div>
<div>Experience: 2+ years</div>
<div><b>Required skills: </b></div>
<div>· Pharmacovigilance knowledge</div>
<div>· Knowledge of CDSCO documentation</div>
<div>· Submitting documents on Sugam Portal</div>
<div>· Complaint handling along with PV</div>
<div><b>Job Description: </b></div>
<div>The position will be an Executive level. Main focus of the candidate will be handling Pharmacovigilance activity along with regulatory.</div>
<div><b>Scope &amp; Missions </b></div>
<div>•Complaints management quality &amp; safety</div>
<div>•Product complaint management ( to be confirmed with QA)</div>
<div>o Centralization of PC</div>
<div>o Supervise investigation and conclusion</div>
<div>o Communication of the result to customer and others stakeholders involved in the process</div>
<div>o Reporting &amp; metrics</div>
<div>o Maintenance Quality System management for product complaint management</div>
<div><b>Vigilance </b></div>
<div>o Local QPPV in India</div>
<div>o Implementation of the process according to Corporate SOP</div>
<div>o Unique contact point for safety notification in Indian territories</div>
<div>o Initiate case processing ( send to corporate)</div>
<div>o Documentation of case</div>
<div>o Local literature in key local publication in order to identify some case report published in the literature</div>
<div>o Local regulatory watch</div>
<div>o Local PSUR schedule management and PSUR management for local products ( if any)</div>
<div>o Local signal detection for local products if any</div>
<div>o Management of dealers and distributors: SDEA, audit, … reconciliation….</div>
<div>o Maintenance of Quality system management</div>
<div>o Maintenance of PVMF according to template provided by Corporate</div>
<div>•Medical information management</div>
<div>•Administrative tasks for regulatory submission</div>
<div><b>KEY Expertise : </b></div>
<div>· Strong knowledge in pharmacovigilance &amp; Product Complaint management ( EU regulation, GVP,)</div>
<div>· Case processing</div>
<div>· PSUR</div>
<div>· Quality system management</div>
<div>· Medical device vigilance knowledge would be interesting</div>
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