PV Systems Solutions & Innovations Associate

Job Title: PV Systems Solutions & Innovations Associate
Location: 1 DNA Way, South San Francisco, CA 94080
Work Model: Hybrid (3 days onsite, 2 days remote)
Duration: 6-month contract (possibility for extension)
Pay Rate: $35/hr. (W2)

Job Overview
We are seeking a PV Systems Solutions & Innovations Associate to support the US Patient Safety Clinical and Vendor Oversight teams. This role ensures compliance with global and local pharmacovigilance (PV) requirements, managing case investigations, study documentation, and vendor oversight under the direction of the Senior Manager, PV Systems Solutions of Operations & Innovations.

Key Responsibilities

• Individual Case Safety Reports (ICSR): Perform submissions, track compliance, review cases, support deviation reporting, and provide updates to leadership.
• Compliance & Risk Mitigation: Conduct root cause analysis for late cases, support implementation of CAPAs, and monitor compliance trends.
• Study Management: Oversee incoming study document reviews, perform Case Transmission Verification (CTV), and coordinate assessments with Patient Safety and Risk Management.
• Market Research Patient (MAP) Support: Perform reconciliations, ensure data integrity in GoMAP, execute quality control reviews (SDQC), and track program documentation.
• Vendor Oversight: Facilitate vendor compliance, track outsourced PV activity metrics, and manage reporting deliverables and training initiatives.
• Promotional Material Review: Support safety-related queries, review promotional content as part of the PRC process, and maintain oversight of patient support programs.
• Operational & Project Support: Drive process improvements, lead or assist in project management, prepare for audits/inspections, and provide safety-related training.

Competencies for Success

• Strong knowledge of the PV environment and compliance requirements.
• Ability to work independently and collaboratively across functions.
• Strong organizational and prioritization skills with attention to detail.
• Demonstrated initiative, accountability, and problem-solving ability.
• Excellent communication, leadership, and interpersonal skills.
• Strong analytical mindset with the ability to translate complex data into actionable insights.

Qualifications

• Bachelor’s degree in Life Sciences or related field preferred (or 5–10 years PV experience in lieu of degree).
• Proficiency with Microsoft Office Suite and Google applications (experience with databases preferred).
• Familiarity with project management methodologies and tools.
• Strong decision-making and problem-solving skills.
• Excellent written and verbal communication skills.
• Ability to travel if required.

#TM2