Senior Safety Scientist II

Revolution Medicines; Redwood City (CA); Vor Ort; USD 186.000 - 233.000; Vollzeit

Zusammenfassung

Revolution Medicines is seeking a Senior Safety Scientist to provide safety science and pharmacovigilance support across the RevMed portfolio. You will oversee safety for clinical studies, review and authorship of protocols, IBs, ICFs, and DSURs, and engage in cross-functional teams to ensure patient safety across development stages.

The role requires postgraduate qualification and 5+ years in drug development with at least 3 years in drug safety, plus strong communication and leadership

Qualifikationen

• Postgraduate qualification in life sciences or health profession.
• 5+ years in drug development with at least 3 years in drug safety.
• Strong communication, leadership, and cross-functional collaboration skills.
• Experience with safety data, regulatory needs, and safety governance.

Aufgaben

• Provide safety science and pharmacovigilance support across RevMed portfolio.
• Review and author clinical trial protocols, IBs, ICFs, DSURs and regulatory documents.
• Lead safety data reviews, sign off on CSRs and aggregate reports.
• Identify safety signals, manage risk mitigation, and support regulatory filings.

Kenntnisse

Pharmacovigilance

Drug safety

Stakeholder management

Presentation skills

Regulatory submissions

Team collaboration

Ausbildung

MD, PharmD, PhD/MSc in life-sciences

Jobbeschreibung

Revolution Medicines is a late‑stage clinical oncology company developing novel targeted therapies for patients with RAS‑addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins, including daraxonrasib (RMC‑6236), elironrasib (RMC‑6291), zoldonrasib (RMC‑9805), and RMC‑5127, all currently in clinical development.

The Opportunity

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 include safety oversight of clinical studies, review and authorship of clinical trial protocols, investigator brochures (IBs), informed consent forms (ICFs), and development safety update reports (DSURs). Additional safety‑related activities involve medical review of individual case safety reports (ICSRs), safety surveillance of assigned products, and active participation in cross‑functional teams.

Responsibilities include:

• Proactive medical safety surveillance of ongoing clinical trials for identification and management of safety signals.
• Prepare and present safety data summaries to internal and external stakeholders.
• Risk management activities, including medical review of ICARs, routine review of safety data, and pertinent scientific literature.
• Acquire and contribute knowledge of relevant drug class and/or competitor safety issues.
• Identify potential clinical safety issues and recommend appropriate risk mitigation measures.
• Participate in preparation and maintenance of relevant sections of clinical trial protocols, IBs, ICFs, DSURs, RMPs, CCDS, and labeling as required.
• Perform safety review of clinical protocols, IB, ICF and other related documents to ensure alignment with the safety strategy and appropriate risk management communication.
• Accountable for the safety components of study reports (CSRs), publications, aggregate reports, and other regulatory documents.
• Conduct signal detection and evaluation activities for assigned products throughout the product lifecycle and lead preparation for escalation to safety governance committees.
• Support implementation of decisions from the signal evaluation process, including updates to core safety information, IB, and other key safety documents.
• Contribute to input related to regulatory filings, New Drug Applications (NDAs) and Biologics License Applications (BLAs), and responses to safety queries from third parties such as regulatory agencies.
• Establish and maintain collaborative working relationships with study team members, CROs, investigators, study sites, vendors, and committees.
• Consistently comply with all governing laws, regulations, RevMed standard operating procedures (SOPs), and other guidelines.
• Independently represent Safety Science at cross‑functional team meetings.
• Contribute to the development of SOPs and Safety Science processes.

Required Skills, Experience and Education

• Relevant postgraduate qualification (e.g., MD, PharmD, PhD/MSc in a life‑sciences discipline, or other post‑graduate health professional qualification).
• Five or more years of drug development experience in the pharmaceutical or related industry, with at least three years 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 (including GVP, 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 the 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 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.

Base Pay Salary Range: $186,000 — $233,000 USD.

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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