Senior Safety Scientist jobs in United States
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Revolution Medicines · 1 day ago

Senior Safety Scientist

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers. The Senior Safety Scientist will provide safety science and pharmacovigilance support across the RevMed portfolio, ensuring safety oversight of clinical studies and contributing to risk management activities.

Health CareLife ScienceMedical
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H1B Sponsor Likelynote

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 include, but are not limited to medical review of 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, IBs (including the reference safety information section), ICFs, DSURs, RMPs, CCDS, and labelling, as required
Perform safety review of clinical protocols, Investigator's Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication
Accountable for the safety components of study reports (i.e., CSRs), publications, aggregate reports, and other regulatory documents
Conducts signal detection and evaluation activities for assigned products for the continuous benefit-risk evaluation throughout the product lifecycle, and contributes/leads preparation for escalation to safety governance committees
Supports implementation of decisions from the signal evaluation process, including updates to core safety information, Investigator’s Brochure and other key safety documents and deliverables
Contributes to input related to regulatory filings, 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

Qualification

MD/PharmD/PHD/MScDrug development experiencePharmacovigilance knowledgeRegulatory safety documentsOncology therapeutic areaPresentation skillsOrganizational skillsCommunication skillsTeam collaboration

Required

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, PV (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 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

Preferred

Demonstrated experience in the oncology therapeutic area through clinical practice, drug development, or other relevant industry experience
In-depth understanding of global pharmacovigilance regulations and guidelines, including GVP, FDA, and EMA requirements
Proficiency with pharmacovigilance databases and tools such as Argus and MedDRA coding
Proven track record in preparing and reviewing regulatory safety documents, including NDAs, DSURs, and risk management plans
Collaborative team player with experience working across cross-functional and global teams, including partnerships with CROs
Strong ability to analyze safety data trends and communicate insights effectively to diverse stakeholders

Benefits

Competitive cash compensation
Robust equity awards
Strong benefits
Significant learning and development opportunities

Company

Revolution Medicines

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Revolution Medicines is an innovative and dynamic organization of expert biologists, chemists, pharmacologists, clinical scientists.

H1B Sponsorship

Revolution Medicines has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (18)
2023 (15)
2022 (8)
2021 (1)
2020 (2)

Funding

Current Stage
Public Company
Total Funding
$2.25B
Key Investors
Royalty PharmaBoxer CapitalNextech Invest
2025-06-24Post Ipo Debt· $250M
2024-12-02Post Ipo Equity· $750M
2023-03-02Post Ipo Equity· $323.6M

Leadership Team

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Luan Wilfong
Chief Human Resources Officer
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Steve Kelsey
President
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Company data provided by crunchbase