Senior Safety Scientist I

About the role

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The Senior Safety Scientist within Global Patient Safety Science is an individual contributor who provides safety science and pharmacovigilance support to all products across the RevMed portfolio, including early and late phase development activities.

Responsibilities

• Proactive medical safety surveillance of ongoing clinical trials for identification and management of safety.
• Prepare and present safety data summaries to internal and external stakeholders.
• Risk management activities including medical review of individual case safety reports (ICSRs), routine review of safety data, and pertinent scientific literature articles.
• Acquire and contribute knowledge of relevant drug class and/or competitor safety issues.
• Identify potential clinical safety issues and recommend appropriate risk mitigation measures.
• Involvement in preparation and maintenance of relevant sections of clinical trial protocols, Investigator’s Brochures (IBs) (including the reference safety information section), Informed Consent Forms (ICFs), Development Safety Update Reports (DSURs), Risk Management Plans (RMPs), Core Company Safety Data Sheets (CCDS), and labelling.
• Perform safety review of clinical protocols, IBs, ICFs, and other related documents to ensure alignment with the safety strategy and appropriateness of risk management strategies and risk communication.
• Accountable for the safety components of study reports (e.g., Clinical Study Reports (CSRs)), publications, aggregate reports, and other regulatory documents.
• Conduct signal detection and evaluation activities for assigned products for continuous benefit-risk evaluation throughout the product lifecycle and contribute/lead preparation for escalation to safety governance committees.
• Support implementation of decisions from the signal evaluation process, including updates to core safety information, IBs, and other key safety documents and deliverables.
• Contribute to input related to regulatory filings (e.g., New Drug Applications (NDAs), Biologics License Applications (BLAs)), and responses to safety queries from third parties, such as regulatory agencies.
• Establish and maintain collaborative working relationships with all key stakeholders (study team members, CROs, investigators, study sites, vendors, committees, etc.).
• Consistently comply with all governing laws, regulations, RevMed standard operating procedures (SOPs), and other guidelines.

Requirements

• A relevant postgraduate qualification (e.g., MD, PharmD, PhD/MSc in a Life Sciences discipline, or other post-graduate health professional qualifications).
• 3 or more years of drug development experience in the pharmaceutical or related industry with at least 1 year in drug safety.
• Proven success in creating and sustaining strong relationships with internal and external business partners across an organization to create positive partnerships.
• Broad understanding of the scientific aspects of safety, pharmacovigilance (PV) (including Good Pharmacovigilance Practices (GVP), Good Clinical Practices (GCP)), and clinical/patient risk management and safety operations.
• Demonstrated ability to lead and influence, with and without authority, in a fast-paced environment.
• Strong presentation skills, effective at summarizing and presenting key considerations and decision points.
• Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
• Detail-oriented with the ability to prioritize tasks and function independently as appropriate.
• Strong organizational skills and an ability to interpret, discuss, and report trial-level data effectively and identify trends.
• Excellent written and verbal communication skills.

Pay

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is $120,000 - $150,000 USD. The range displayed is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.