ClinGroup
Pharmacovigilance specialist Jobs in Oman
SHOULD BE BASED IN OMAN – candidates who are not in oman will not be considered.
Requirements:
• Meet national requirements for the local QPPV.
• Prepare, maintain and test PV BCP.
• Ensure PV/inspection readiness and participate in PV audits / inspections.
• Provide input into individual contracts. Maintain and oversee local SLAs and PVAs.
• Prepare the local PSMF, if applicable.
• Oversight and management of clinical safety and post-marketing safety function of the affiliate.
• Ensure PV systems and procedures are appropriately implemented.
• Manage product-related medical safety issues and input to GPSE on product quality issues.
• Participate in QPPV forum. Cascade relevant PV information to key interfaces.
• Issue escalation within area PV organization.
• Supervise safety reporting and other PV activities for licensed products.
• Oversee and provide input to local RMP and RMM.
• Ensure local signal detection, as required.
• Monitor Organized Data Collection programs
• As applicable, review protocols for local studies
• Manage and oversee local literature search
• Conducts PV training of all local PV employees and non-PV staff
• Provide Regional Hub with PV compliance information
• Oversee and provide input to Quality Events and CAPAs