Rev Ops Associate on the Revenue Operations and Strategy team building Hinge Health's financial engine. Ensuring revenue retention and billing accuracy in a fast - paced environment.
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
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