Safety Scientist

Revolution Medicines•Redwood City, CA

1d•Hybrid

About The Position

Revolution Medicines is a late-stage clinical oncology company focused on developing novel targeted therapies for patients with RAS-addicted cancers. Their R&D pipeline includes several RAS(ON) inhibitors currently in clinical development. The Safety Scientist, an individual contributor within Global Patient Safety Science, provides safety science and pharmacovigilance support for all products across the RevMed portfolio, covering both early and late phase development activities. This role involves supporting clinical studies, reviewing clinical trial protocols, assisting with updates to IBs and ICFs, and authoring DSURs. Key safety-related activities also include medical review of individual case safety reports (ICSRs), safety surveillance of assigned products, and active participation in cross-functional teams. The Safety Scientist is expected to develop and maintain a thorough understanding of the safety profile for their assigned product(s).

Requirements

A relevant postgraduate qualification (e.g., MD, PharmD, PHD/MSc in a Life sciences discipline, or other post-graduate health professional qualifications).
1 or more years of drug development experience in the pharmaceutical or related industry.
Detail-oriented with ability prioritize tasks and function independently as appropriate.
Strong learning orientation, curiosity, and commitment to science and patients.
Excellent written and verbal communication skills.

Nice To Haves

Understanding of the scientific aspects of safety, PV (including GVP, GCP), and clinical/patient risk management.
Exposure to Safety Operations and experience with individual case review.
Knowledge and/or experience with clinical trial management and data review.

Responsibilities

Proactive medical safety surveillance of ongoing clinical trials for identification of safety
Conduct ongoing safety data reviews; prepare and present summaries to internal stakeholders.
Medical review of individual case safety reports, routine review of safety data and pertinent scientific literature articles.
Identify potential clinical safety issues for ongoing clinical trials based on emerging safety data.
May perform safety reviews of relevant sections of clinical trial protocols, Investigator’s Brochures (including reference safety information), clinical study reports, informed consent forms, DSURs, and other study related documents, as required.
Supports authoring or otherwise contributes to the preparation of aggregate safety reports and risk management plans (RMPs).
Conducts signal detection and evaluation activities for assigned products in collaboration with senior Safety Science team member(s) as part of the continuous benefit-risk evaluation throughout the product lifecycle.
Establish and maintain collaborative working relationships with all key stakeholders (e.g., clinical study teams, study sites, CROs).
Consistently comply with all governing laws, regulations, RevMed standard operating procedures (SOPs) and other guidelines.