Qureos Mentor

productlife group

<div><div><div><div><p>We are looking for a Team lead/ Manager/ senior medical advisor/reviewer proficient in all aspects of clinical and post-marketing drug safety.</p>
</div></div><div><h2 class="jobSectionHeader"><b>Responsibilities:</b></h2>
<div><p>Clinical Phase:</p>
<ul>
<li>Lead as a medical monitor/Medical expert</li>
<li>Medical Monitoring experience is a must and the ability to effectively communicate with the clients, attend investigator meetings as required and provide support to sites regarding protocol or possible drug interactions is essential.</li>
<li>Review and provide feedback on study protocols as needed.</li>
<li>Deliver therapeutic area training for all case processing team.</li>
<li>May require 24/7 availability depending on the client needs for possible queries or protocol deviations resulting in potential harm to patients.</li>
<li>Drafting medical monitoring plans (MMP) and ensuring compliance.</li>
<li>Reviewing adverse events (AEs) reported by study sites, assessing their severity, and determining appropriate actions (like dose adjustments or trial discontinuation).</li>
<li>Make assessments on SUSAR reportability.</li>
<li>Perform the review and interpret clinical data, ensure protocol compliance and draft monthly reports for the clients (with presentation at periodic meetings if required).</li>
<li>Develop and update current training materials in line with GCP and GVP requirements for medical review of all cases.</li>
</ul>
<p>Post-Marketing (Pharmacovigilance):</p>
<ul>
<li>Lead the medical reviewers</li>
<li>Medical review of the ICSRs (Spontaneous, literature)</li>
<li>Support in causality, medical assessment, benefit-risk evaluation of the medicinal product.</li>
<li>Mentor junior medical reviewers and perform additional review of cases to ensure competency.</li>
<li>Provide feedback and ongoing workshops to develop the medical reviewers.</li>
<li>Participate in audits and inspections as required</li>
<li>Ensure understanding of client needs, conventions and ensure expectations are met and exceeded</li>
<li>Training and mentoring other team members</li>
</ul></div></div><div><h2 class="jobSectionHeader"><b>Required Education:</b></h2>
<div><p>MBBS, or MD (Doctor of Medicine)</p><br>
<p></p>
</div></div><div><h2 class="jobSectionHeader"><b>Required Experience :</b></h2>
<div><ul><li>Experience in leading medical review teams</li>
<li>Client communications</li>
<li>Safety Database experience</li>
<li>Minimum 10 years experience working for service providers or pharmaceutical company</li>
<li>At least 5-7 years of experience as a Medical Monitor or clinical phase</li>
</ul></div></div><div><h2 class="jobSectionHeader"><b>Required Technical Skills:</b></h2>
<div><ul><li>Microsoft package</li>
<li>Pharmaceutical background &ndash; strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.</li>
<li>Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment.</li>
<li>Working knowledge of EDC systems</li>
<li>Good Medical knowledge and Pharmacology understanding</li></ul></div></div></div></div>

Medical Advisor – VAF

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Medical Advisor – VAF