The Vendor Operations Analyst II coordinates with the appropriate support functions to execute QA/QC, metrics tracking and SP communications for his/her assigned SP.
Oversight / Project Management
Understands the vendor management framework set by the Head of SP PV Oversight an SP PV Oversight Team Lead and translates the requirements into reporting deliverables (e.g., QA/QC metrics, action items, etc.)
Works with the Vendor Lead on the oversight of GVP and MAP SPs
Supports with the Vendor Lead on all operations performed, including the implementation of policies/procedures that ensure efficient and compliant operations
Ensures quality and PV requirements are met in accordance with contractual obligations.
Facilitates and participates in SP oversight activities such as SP meetings.
Develops agenda and facilitates meetings with SP
Tracks statuses for critical milestones and metrics
Creates action items and follow-ups on action items
Appropriately escalates to SP PV Oversight Team Lead and Vendor Lead as required
Communicates closely with local cross functional teams within USDS to ensure the appropriate level of support is achieved to ensure oversight.
Determines priorities and resource load balancing to manage backlogs, action items, and business as usual.
Leads, coordinates, and collates QC error rates, QC metrics, trends, and gaps for the SP PV Oversight Team Lead and Vendor Lead.
Leads or assists 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.
Understands the PV environment and works with Vendor Lead and SP PV Oversight Team Lead to identify SP compliance risks.
Monitors SP compliance to applicable SOPs and Key Performance Indicators as detailed in the Service Agreement and global/local requirements.
Oversees Corrective and Preventative Actions by the SP, as required.
Supports SP PV Oversight Team Lead and Vendor Lead during audits and inspections.
Issue / Risk Management
Acts as a day-to-day point of contact with USDS SPs and ensures strong relationships and communication are built between GNE and the SP.
Acts as a point of inquiry for any questions/concerns raised by the SP with appropriate resolution or escalation by Roche/GNE
Provides regular feedback on performance and quality checks to the SP working together with SP PV Oversight Team Lead and Vendor lead.
Working together with the SP PV Oversight Team Lead and Vendor Lead, communicates any processes or procedural changes
Escalates any critical decisions or discussions to the Vendor Lead and SP PV Oversight Team Lead
Provides support to SP PV Oversight Team Lead and Vendor Lead by answering questions on Vendor Management reports and deliverables.
Escalates SP risks to the Vendor Lead and Team Lead as required.
Actively identifies process improvement opportunities, gaps, and risks and communicates to SP PV Oversight Team Lead and Vendor Lead to support continuous quality improvement.
Competencies Identified for Success:
Exemplifies strong, dynamic leadership and demonstrates decisiveness and appropriate decision-making abilities as demonstrated by systematic gathering of information, appropriately assessing the complexity of issues, and prioritization of tasks in a timely manner within the scope of responsibility and escalates identified issues to management in a timely fashion.
Works effectively, independently, and collaboratively as a team member with global stakeholders and external business partners,
Strong organizational skills, detail oriented and adapts in a fast paced, changing environment
Demonstrates ownership, initiative, accountability, strong organizational skills, and is solution oriented Excellent communication skills, both written and verbal
Ability to actively exchange knowledge and ideas
Able to identify potential business gaps and leads in the development and implementation of process solutions
Able to handle the pressure associated with and adapts to a fast-paced, changing environment
Demonstrates ownership, initiative, accountability, strong organizational skills, and is solution oriented
Inspires others to do their best work by offering encouragement and support Maintains personal and corporate integrity
Education, Experience, and Other Requirements:
Life sciences degree BSc minimum
5+ years in pharmacovigilance or compliance-related role required
Advanced analytic and computer skills (e.g., Microsoft Excel, other data visualization tools) preferred
Able to be agile and adapt to shifting priorities and needs
Able to be flexible to accommodate differences in vendor time zones
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
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