Senior Safety Scientist I

Revolution Medicines•Redwood City, CA

7h•$164,000 - $205,000•Onsite

About The Position

The Senior Safety Scientist I is an individual contributor within Global Patient Safety Science, providing safety science and pharmacovigilance support across Revolution Medicines’ portfolio, including early- and late-phase development. The role oversees clinical study safety and reviews and authors safety-related clinical documents, including protocols, Investigator’s Brochures (IBs), informed consent forms (ICFs), and Development Safety Update Reports (DSURs). It also includes medical review of individual case safety reports (ICSRs), safety surveillance of assigned products, and active participation on cross-functional teams. The role develops and maintains knowledge of assigned products’ safety profiles and conducts ongoing safety surveillance, signal detection, and benefit-risk evaluation. The Senior Safety Scientist prepares and presents safety summaries, identifies potential safety issues, recommends risk mitigation, and contributes to safety governance, regulatory submissions, and safety communications. The position works collaboratively with internal and external stakeholders and complies with applicable laws, regulations, company SOPs, and guidelines.

Requirements

Relevant postgraduate qualification, such as an MD, PharmD, PhD/MSc in a life sciences discipline, or another postgraduate health professional qualification.
At least 3 years of drug development experience in the pharmaceutical or related industry, including at least 1 year in drug safety.
Proven ability to create and sustain strong relationships with internal and external business partners.
Broad understanding of safety science, pharmacovigilance (including GVP and GCP), clinical and patient risk management, and safety operations.
Ability to lead and influence with and without authority in a fast-paced environment.
Strong presentation skills and ability to summarize and present key considerations and decision points.
Collaborative approach and motivation to deploy innovative approaches and technologies in a high-energy environment.
Attention to detail and ability to prioritize tasks and work independently as appropriate.
Strong organizational skills and ability to interpret, discuss, and report trial-level data effectively and identify trends.
Excellent written and verbal communication skills.

Nice To Haves

Independent leadership of drug safety activities for clinical programs, including signal evaluation and benefit-risk assessment.
Experience authoring and reviewing key safety documents, such as DSURs, IB updates, and protocol or CSR safety sections.
Ability to represent safety on cross-functional teams.
Demonstrated scientific judgment and ability to work autonomously in a fast-paced environment.
Exposure to global development programs and regulatory safety expectations.
Experience improving pharmacovigilance processes or implementing new safety tools or technologies.
Therapeutic area experience in oncology.

Responsibilities

Conduct proactive medical safety surveillance of ongoing clinical trials to identify and manage safety signals.
Prepare and present safety data summaries to internal and external stakeholders.
Perform medical review of ICSRs and routinely review safety data and relevant scientific literature.
Acquire and contribute knowledge of relevant drug classes and competitor safety issues.
Identify potential clinical safety issues and recommend appropriate risk mitigation measures.
Prepare and maintain relevant safety sections of clinical trial protocols, IBs (including reference safety information), ICFs, DSURs, RMPs, CCDS, and labeling, as required.
Review clinical protocols, IBs, ICFs, and related documents for alignment with safety strategy and appropriate risk management and communication.
Own safety components of clinical study reports, publications, aggregate reports, and other regulatory documents.
Conduct signal detection and evaluation for assigned products throughout the product lifecycle and contribute to or lead preparation for escalation to safety governance committees.
Support implementation of signal evaluation decisions, including updates to core safety information, IBs, and other key safety documents and deliverables.
Contribute to regulatory filings, NDAs, BLAs, and responses to safety queries from regulatory agencies and other third parties.
Establish and maintain collaborative relationships with study teams, CROs, investigators, study sites, vendors, committees, and other stakeholders.
Comply with governing laws, regulations, company SOPs, and other guidelines.