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Safety Partnering Associate Jobs

Company

Mindlance

Address South San Francisco, CA, United States
Employment type CONTRACTOR
Salary
Category Biotechnology Research,Pharmaceutical Manufacturing
Expires 2024-05-04
Posted at 7 months ago
Job Description

Role: Safety Partnering Associate

Location: South San Francisco, CA

Duration: 06 months (Possible Extension)


Rate : $40 - $49/hr. on W2


:

• The Associate Safety Partnering (ASP) is responsible for supporting oversight of DiCELA (Digital Customer Engagement and Listening Activities) and Patient Facing Roles (PFRs), coordinating coordinates with the appropriate support functions to execute QA/QC, metrics tracking and Safety Partnering communications for his/her assigned business partners (BP) including (i.e., DiCELA Channel Owners, DiCELA Service Providers, and Patient Facing Role Partners. and DiCELA Service ProvidersSP).


Job Duties/Responsibilities: Oversight / Project Management

• Understands the vendor management framework set by the Head of SP PV Oversight and SP PV Oversight 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 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 Manager 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 Manager 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 Safety Partnering Lead and MAPs and Safety Partnering Manager to identify safety partnering compliance risks.

Monitoring Performance • 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 Manager 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 communications are built between client and the SP. • Acts as a point of inquiry for any questions/concerns raised by the SP with appropriate resolution or escalation by client • Provides regular feedback on performance and quality checks to the SP working together with • MAPs and Safety Partnering Manager and Safety Partnering Lead. • Working together with the SP PV Oversight Manager and Vendor Lead, communicates any processes or procedural changes • Escalates any critical decisions or discussions to the Vendor Lead and SP PV Oversight Manager • Provides support to SP PV Oversight Manager and Vendor Lead by answering questions on Vendor Management reports and deliverables. • Escalates SP* risks to the Vendor Lead and SP PV Oversight Manager as required. • Actively identifies process improvement opportunities, gaps, and risks and communicates to • SP PV Oversight Manager 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 (or ?10 years’ experience in a similar role) • 3 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 • Able to be flexible to accommodate differences in vendor time zones


“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”