Vendor Operations Analyst #PP

2 weeks ago

South San Francisco, United States Avispa Technology Full time

Job DescriptionVendor Operations Analyst ROCGJP00026322 #PPA leading biotechnology company is seeking a Vendor Operations Analyst. The successful candidate will support the Vendor Lead on all operations performed, including the implementation of policies/procedures that ensure efficient and compliant operations. The ideal candidate has 5+ years in pharmacovigilance or compliance-related role required.Vendor Operations Analyst Pay and Benefits:Hourly pay: $40-$50/hr (Pay varies based on candidate's location and experience)Worksite: Leading biotechnology company (Remote, Candidates must be located in the United States and work in Pacific Time)W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program40 hours/week, 7 Month AssignmentVendor Operations Analyst Responsibilities: Understand the vendor management framework set by the Head of MAP & Safety Partnering and translate the requirements into reporting deliverables (e.g., QA/QC metrics, action items, etc.) Work with the Vendor Lead on the oversight of GVP/MAP SPs.Support the Vendor Lead on all operations performed, including the implementation of policies/procedures that ensure efficient and compliant operations.Ensure quality and PV requirements are met in accordance with contractual obligations. Facilitate and participates in SP oversight activities such as SP meetings.Develop agenda and facilitates meetings with SP.Track statuses for critical milestones and metrics.Create action items and follow-ups on action items.Appropriately escalate to MAP Management Team and Vendor Lead as required.Communicate closely with local cross-functional teams within US PS to ensure the appropriate level of support is achieved to ensure oversight.Determine priorities and resource load balancing to manage backlogs, action items, and business as usual. Lead, coordinate, and collate QC error rates, QC metrics, trends, and gaps for the MAP Management and Vendor Lead.Lead or assist in the tracking and investigation of case processing-related metrics (e.g., late case investigation) including compliance-related issues set by the vendor management strategy.Understand the PV environment and works with Vendor Lead and Head of MAP and Safety Partnering to identify SP compliance risks.Monitor Performance.Monitor SP compliance to applicable SOPs and Key Performance Indicators as detailed in the Service Agreement and global/local requirements.Oversee Corrective and Preventative Actions by the SP, as required.Support MAP management and Vendor Lead during audits and inspections.Issue / Risk Management.Act as a day-to-day point of contact with US PS SPs and ensure strong relationships and communication are built between GNE and the SP.Act as a point of inquiry for any questions/concerns raised by the SP with appropriate resolution or escalation.Provide regular feedback on performance and quality check to the SP working together with MAP Management and Vendor lead.Working together with the MAP Management and Vendor Lead communicates any processes or procedural changes.Escalate any critical decisions or discussions to the Vendor Lead and Head of MAP & Safety Partnering. Provide support to MAP Management and Vendor Lead by answering questions on Vendor Management reports and deliverables.Escalate SP risks to the Vendor Lead and MAP Management as required.Actively identify process improvement opportunities, gaps, and risks and communicates to MAP Management and Vendor Lead to support continuous quality improvement. Vendor Operations Analyst Qualifications: 5+ years in pharmacovigilance or compliance-related role required.Life sciences degree BSc minimum (or 10 years' experience in a similar role).Medical terminology experience preferred.Writing experience; science/medical writing highly desirable.Advanced analytic and computer skills (e.g., Microsoft Excel, other data visualization tools) preferred.Able to travel as per business needs required.Able to be agile and adapt to shifting priorities and needs.Able to be flexible to accommodate differences in vendor time zones.

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    2 weeks ago

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