MSI Pharma are working with a world renowned bio-tech company to hire 2 PV Vendor management specialist in the Bay area on 6 month W2 contracts
- Understands the vendor management framework set by the Head of PV Operations and Vendor Strategy Manager 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 Vendors
- Facilitates and participates in vendor and PV oversight activities such as vendor meetings
- Communicates closely with local cross functional teams within US Drug Safety (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 Vendor Strategy Manager and Vendor Strategy Lead.
- Leads or assists in the tracking and investigation of case processing related metrics including compliance related issues set by the vendor management strategy.
- Understands the PV environment and works with Vendor Strategy Lead and Vendor Strategy Manager to identify vendor compliance risks.
- 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
- sciences degree BSc minimum (or >10 years experience in a similar role)
- 5+ years in pharmacovigilance or compliance-related role required
- Advanced analytic and computer skills (e.g., Microsoft Excel, other data visualization tools) preferred
- Medical terminology experience preferred
- Writing experience; science/medical writing highly desirable
- Able to travel as per business needs required
- Able to be agile and adapt to shifting priorities and needs