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Medical Safety Operations Manager

Revolution Medicines

Redwood City, CA, US
  • Job Type: Full-Time
  • Function: Life Sciences R&D/Engineering
  • Industry: Biotechnology
  • Post Date: 04/02/2024
  • Website: www.revmed.com
  • Company Address: 700 Saginaw Dr, Redwood City, California 94063, US

About Revolution Medicines

REVOLUTION Medicines discovers and develops new drugs that harness the therapeutic potential of frontier oncology targets on behalf of cancer patients.

Job Description

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 scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

As a Medical Safety Operations Manager, you will be responsible for the management and oversight of Medical Safety functional activities in the execution of safety reporting for the assigned clinical programs.  This role is an individual contributor with team leadership responsibilities, reporting into the Associate Director Medical Safety Operations Team Lead.

Specifically, you will be responsible for:

  • Representing Medical Safety in different cross functional team meetings.

  • Collaborating with other functional groups to achieve clinical program goals.

  • Overseeing Pharmacovigilance Contract Research Organization (PV CRO) in the execution of safety reporting in clinical studies.

  • Managing PV CROs to ensure compliance with required timelines, that potential issues are being communicated, and resolution is achieved in a timely manner.

  • Overseeing reporting of safety reports to global regulatory authorities, central IRB/ethics committees, investigators to ensure compliance with global regulatory requirements.

  • Ensuring timely set up of global safety reporting and safety database in assigned clinical programs.

  • Supporting authoring and updates of clinical trial protocols, informed consent forms, Investigator Brochure (including the Reference Safety Information section), and aggregate reports.

  • Supporting the execution and maintenance Safety Data Exchange Agreements/Pharmacovigilance Agreements with business partners.

  • Collaborating with other functional groups in SAE reconciliation and SAE query resolution activities.

  • Supporting medical safety team in other PV activities appropriate to experience and expertise.

Required Experience, Skills, and Education:

  • Bachelor’s degree in a healthcare field with a minimum of 3-6 years of pharmacovigilance operational activities.

  • Strong experience working with CROs/vendors and management of external resources.

  • Strong background in safety reporting regulatory compliance and international safety reporting/regulations in clinical trials.

  • Experience in working with global clinical trials, investigator sponsored trials, compassionate use programs, business partnerships is preferred.

  • Able to problem solve, multi-task, prioritize options, work independently, anticipate challenges and execute assigned deliverables.

  • Attention to detail and excellent written and verbal communication skills.

  • Excellent interpersonal skills including ability to work in cross-functional team environments and with external vendors.

  • Exercise discretion regarding highly confidential internal and external communications.

  • Software Knowledge: MS Office 365 (Outlook, Word, PowerPoint, Excel), Adobe Acrobat

Revolution Medicines currently requires that all personnel and visitors to its offices be fully vaccinated against COVID-19. This role will require that the employee meet with company employees and work from the company’s offices. Given that these essential functions of the role must be performed on-site, this position requires full COVID-19 vaccination, subject to applicable law.

The expected salary range for this role is $120,000 to $158,000. An individual’s position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics. Base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

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