Senior Safety Scientist I

Revolution Medicines•Redwood City, CA

13h•$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 provides safety oversight for clinical studies and supports safety surveillance and risk management for assigned products. The scientist develops and maintains an understanding of product safety profiles and contributes to cross-functional teams and safety governance activities. The role includes reviewing and authoring clinical and safety documents, conducting medical review of individual case safety reports, evaluating safety data and scientific literature, and identifying potential safety issues and appropriate risk-mitigation measures. The position also contributes to signal detection and evaluation, ongoing benefit-risk assessment, regulatory filings and responses, and implementation of safety decisions across product documentation. The Senior Safety Scientist I works with internal and external stakeholders and complies with applicable laws, regulations, company procedures, and guidelines.

Requirements

Relevant postgraduate qualification, such as an MD, PharmD, PhD or MSc in a life sciences discipline, or another postgraduate health professional qualification.
At least 3 years of drug development experience in the pharmaceutical or a related industry, including at least 1 year in drug safety.
Demonstrated success creating and sustaining 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.
Ability to work collaboratively and interest in deploying innovative approaches and technologies.
Detail-oriented, able to prioritize tasks, and able to 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, Investigator’s Brochure updates, and protocol or clinical study report safety sections.
Ability to represent safety on cross-functional teams.
Demonstrated scientific judgment and ability to operate 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.
Oncology therapeutic-area experience.

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.
Conduct medical review of individual case safety reports and routine review of safety data and relevant scientific literature.
Build and contribute knowledge of relevant drug-class and competitor safety issues.
Identify potential clinical safety issues and recommend appropriate risk-mitigation measures.
Prepare and maintain safety sections of clinical trial protocols, Investigator’s Brochures, informed consent forms, DSURs, risk management plans, CCDS, and labeling, as required.
Review clinical protocols, Investigator’s Brochures, informed consent forms, and related documents to ensure 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, support continuous benefit-risk evaluation, and contribute to or lead preparation of escalations to safety governance committees.
Support implementation of signal evaluation decisions, including updates to core safety information, Investigator’s Brochures, and other safety documents and deliverables.
Contribute safety input to regulatory filings, including NDAs and BLAs, and respond to safety queries from third parties such as regulatory agencies.
Maintain collaborative working relationships with study teams, CROs, investigators, study sites, vendors, committees, and other stakeholders.
Comply with governing laws, regulations, company SOPs, and other guidelines.