Qureos Mentor

Ray-CRO

we are Hiring Deputy QPPV<ul><li>Apply the back up procedures in case of QPPV absence</li><li>Serves as Point of contact for the Regulatory authorities on behalf of the contracting MAH and responding promptly to any request from the regulatory authorities.</li><li>Have access to RAY-CRO PSMF and performing its updates and have sufficient authority to ensure its compliance to the regulations</li><li>Participate in preparation and regular update of RAY PV SOPs</li><li>Participate in establishing pharmacovigilance system for delegating Marketing authorization holders</li><li>Participate and handling of process as applicable all spontaneous and solicited safety reports as ICSRs for contracting MAHs and regulatory obligations and submitting them as per regulatory timelines</li><li>Perform regular Reconciliation with the concerned departments in the contracting MAHs</li><li>Perform Literature search weekly for the contracting MAHs products</li><li>Participate in Signal Detection and evaluation from PV database or screened literature</li><li>Having overview of the safety profiles and handling emerging safety issues as applicable that affect risk/benefit balance of the contracting MAHs&rsquo; product</li><li>Participate in handling medical information requests and product defects either associated with AE or not about the contracting MAHs&rsquo; products</li><li>Participate in preparation and Submission of PBRERs and their national appendix and addendum to clinical overview, as applicable, according to the regulatory obligations and timelines for contracting MAHs&rsquo; products</li><li>Participate in the preparation and Submission of RMPs with different displays, as applicable, according to the regulatory obligations and timelines for contracting MAHs&rsquo; products</li><li>Participate in providing input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals);</li><li>Help contracting MAHs&rsquo; regulatory personnel in preparation and Submission of Safety Variations, as applicable, according to the regulatory obligations and timelines</li><li>Participate in handling Risk Minimization measures for the contracting MAHs&rsquo; products</li><li>File, store, and archive safety-related data.</li><li>Prepare for audits/inspections from regulatory authorities or contracted MAH in the department or internal audits for the department to ensure compliance with company and regulatory obligation.</li><li>Interact with different contracting MAH&rsquo;s Departments as applicable for integrating PV system (eg. Medical Information, Regulatory Affairs, Product Quality, Clinical Development, Sales and Marketing, Patient support Programs and Quality Assurance)</li><li>Participate in performing trainings RAY personnel and contracting MAHs&rsquo; personnel as requested</li><li>Reviewing pharmacovigilance part and safety issues in protocols of post-authorization safety studies sponsored by the contracting MAHs for full PV services</li><li>Has oversight over SDEAs with partners and PV database operations and its validation</li><li>Participate in PV assessment or Audits or third parties related to the department.</li></ul>Must be resident in KSAJob Type: Full-timeJob Type: Full-time

Deputy QPPV

Join Ray-CRO and explore 1   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Ray-CRO

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Deputy QPPV