Senior PV Operations Specialist

Role Summary

The Senior Pharmacovigilance Operations Specialist works within the Global Patient Safety team to ensure patient safety by maintaining up-to-date safety profiles across the product lifecycle, analyzing safety information and validating safety signals. The role involves coordinating ICSR processing, safety submissions, and cross-functional collaboration to support risk management and pharmacovigilance activities for Verastem products.

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.

Qualifications

• 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.