Hybrid Senior PV Operations Specialist

at Verastem Oncology

• Job title: Senior PV Operations Specialist
• Job type: Full Time
• Experience level: Senior
• Salary: $116,000 - $143,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Boston, United States

About the role

• Managing drug safety case management vendor and compliance for Verastem Oncology. Overseeing PV operations and ensuring accurate safety information throughout product life cycle.

Responsibilities

• Responsible for operational activities of ICSRs processed by PV case processing vendor.
• Oversee day-to-day ICSR operational activities, processes, training and compliance of PV case processing vendor.
• Ensure timely submission compliance of ICSRs to global regulatory authorities, business partners, CROs and other parties.
• Provide oversight of ICSR regulatory submissions to ensure compliance with global regulations.
• Ensure data reconciliation of the safety and clinical databases for Serious Adverse Events.
• Effectively utilize metrics to assess productivity, opportunities for workflow and quality improvement, and to measure effectiveness of change initiatives.
• Work with VP, PV Operations and Compliance, and other GPS colleagues to ensure PV compliance and inspection readiness.
• Support data readiness for generation and submission of aggregate reports (e.g., DSUR, PBRER, and IDMC listings).
• Collaborate with PV and other functionals to coordinate case management, aggregate reporting, and signal detection activities.
• Collaborate with the preparation of and updates to safety-related study documents (e.g., Safety Management Plans, Reconciliation activities, Database lock activities, etc.)
• Work with VP, PV Operations and Compliance, Quality Assurance team to ensure PV compliance and inspection readiness.
• Additional safety related duties assigned.

Requirements

• Minimum of bachelor’s degree in nursing, pharmacy, or other health care related profession.
• Minimum 5 years of experience in pharmacovigilance operations
• Minimum 4 years of experience in managing end-to-end ICSR case processing activities either internally or through PV vendor(s)
• Experience with Argus safety databases, EDC systems, and electronic document management systems.
• Knowledge of GCPs, GVPs, FDA, EMA, ICH guidelines, and international regulations.
• Proficiency in MedDRA and WHO Drug dictionaries.
• Ability to thrive in a fast-paced, start-up environment and manage multiple priorities.

Benefits

• Annual bonus
• Equity compensation
• Competitive benefits package