Global Patient Safety Operations Associate
About the position Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: Assist with the oversight of the Pharmacovigilance Contract Research Organization (PV CRO) performing case management and study support activities. Assist with the management of the PV CRO to ensure compliance within the required timelines. Provide vendors with relevant clinical study documents and updates. Coordinate the review and filing of study plans and associated documents. Coordinate the review and filing of PV CRO documents and monthly compliance reports. Track and maintain well-organized department files, including listings and trackers received from CROs. Support eTMF oversight of safety case files and relevant documents with PV and clinical CROs. Participate and review TMF plans to capture PV and clinical CRO’s filing responsibilities. Maintain PV CRO distribution contact lists and oversee Clinical CRO site contact lists. Maintain meeting materials, schedule meetings, develop agendas, and track meeting minutes. Assist with MedDRA and WHO Drug coding impact analysis review. Prepare aggregate periodic reports for departmental review and CRO distribution. Assist with Standard Operating Procedure (SOP) cross-functional review in Quality Management System. Perform administrative tasks to support GPS team, as needed. Support GPS Operations team in other PV activities as appropriate to experience and expertise.
Responsibilities
- Assist with the oversight of the Pharmacovigilance Contract Research Organization (PV CRO) performing case management and study support activities.
- Assist with the management of the PV CRO to ensure compliance within the required timelines.
- Provide vendors with relevant clinical study documents and updates.
- Coordinate the review and filing of study plans and associated documents.
- Coordinate the review and filing of PV CRO documents and monthly compliance reports.
- Track and maintain well-organized department files, including listings and trackers received from CROs.
- Support eTMF oversight of safety case files and relevant documents with PV and clinical CROs.
- Participate and review TMF plans to capture PV and clinical CRO’s filing responsibilities.
- Maintain PV CRO distribution contact lists and oversee Clinical CRO site contact lists.
- Maintain meeting materials, schedule meetings, develop agendas, and track meeting minutes.
- Assist with MedDRA and WHO Drug coding impact analysis review.
- Prepare aggregate periodic reports for departmental review and CRO distribution.
- Assist with Standard Operating Procedure (SOP) cross-functional review in Quality Management System.
- Perform administrative tasks to support GPS team, as needed.
- Support GPS Operations team in other PV activities as appropriate to experience and expertise.
Requirements
- Bachelor’s degree in natural or health sciences with 2 years of experience or a minimum of 4-5 years of relevant industry experience in lieu.
- Knowledge of Good Clinical Practice (GCP) Guidelines.
- Experience in clinical trial conduct and safety reporting.
- Good understanding of Software: MS Office 365 (Outlook, Word, PowerPoint, Excel), Adobe Acrobat, eTMF software, quality management systems (i.e., Veeva Systems).
- Reliable, self-motivated, focused, positive attitude, proactive and solution-oriented problem solver, able to adapt to changes in priorities and tasks.
- Attention to detail and excellent written and verbal communication skills.
- Demonstrate the ability to manage time, prioritize tasks, and organize information effectively to meet timelines.
- Excellent interpersonal skills include ability to work in cross-functional team environments and with external vendors.
- Able to create and sustain strong working relationships with remote staff use video conference and instant message, as needed.
- Exercise discretion regarding highly confidential internal and external communications.
Nice-to-haves
- Experience working with CROs/vendors and management of external resources is preferred.
- Opportunities for successful candidates will be available to learn about safety reporting in global clinical trials and other aspects of drug safety.
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