Global Patient Safety Operations Associate en Revolution Medicines

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.

Required Skills, Experience and Education:

• 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).

Preferred Skills:

• 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.

• 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. #LI-Hybrid  #LI-YG1