Vendor Operations Analyst ROCGJP00026322 #PP

A 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 Program
• 40 hours/week, 7 Month Assignment

Vendor 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.