Deputy QPPV

we are Hiring Deputy QPPV

• Apply the back up procedures in case of QPPV absence
• 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.
• Have access to RAY-CRO PSMF and performing its updates and have sufficient authority to ensure its compliance to the regulations
• Participate in preparation and regular update of RAY PV SOPs
• Participate in establishing pharmacovigilance system for delegating Marketing authorization holders
• 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
• Perform regular Reconciliation with the concerned departments in the contracting MAHs
• Perform Literature search weekly for the contracting MAHs products
• Participate in Signal Detection and evaluation from PV database or screened literature
• Having overview of the safety profiles and handling emerging safety issues as applicable that affect risk/benefit balance of the contracting MAHs’ product
• Participate in handling medical information requests and product defects either associated with AE or not about the contracting MAHs’ products
• 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’ products
• Participate in the preparation and Submission of RMPs with different displays, as applicable, according to the regulatory obligations and timelines for contracting MAHs’ products
• 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);
• Help contracting MAHs’ regulatory personnel in preparation and Submission of Safety Variations, as applicable, according to the regulatory obligations and timelines
• Participate in handling Risk Minimization measures for the contracting MAHs’ products
• File, store, and archive safety-related data.
• 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.
• Interact with different contracting MAH’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)
• Participate in performing trainings RAY personnel and contracting MAHs’ personnel as requested
• Reviewing pharmacovigilance part and safety issues in protocols of post-authorization safety studies sponsored by the contracting MAHs for full PV services
• Has oversight over SDEAs with partners and PV database operations and its validation
• Participate in PV assessment or Audits or third parties related to the department.

Must be resident in KSA

Job Type: Full-time

Job Type: Full-time