We’re seeking a Temp Senior Safety Scientist for our well-known client based in Redwood City, CA. This will be individual contributor who provides safety science and pharmacovigilance support to products across the portfolio, including early- and late-phase development activities. 
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Responsibilities
The Senior Safety Scientist will develop and maintain an understanding of the safety profile of assigned product(s).
Responsibilities include:
 

• Responsible for safety oversight of clinical studies and the review and authoring of clinical trial protocols, Investigator’s Brochures (IBs), Informed Consent Forms (ICFs), and Development Safety Update Reports (DSURs).
• Additional safety-related activities include medical review of individual case safety reports (ICSRs), safety surveillance of assigned products, and active participation on cross-functional teams.
• Proactive medical safety surveillance of ongoing clinical trials for identification and management of safety issues
• Preparation and presentation of safety data summaries to internal and external stakeholders
• Risk management activities, including medical review of ICSRs, routine review of safety data, and relevant scientific literature
• Acquisition and contribution of knowledge related to drug class and/or competitor safety issues
• Identification of potential clinical safety issues and recommendation of appropriate risk mitigation measures
• Preparation and maintenance of relevant sections of:
  • Clinical trial protocols
  • Investigator’s Brochures (including reference safety information)
  • Informed Consent Forms (ICFs)
  • DSURs, RMPs, CCDS, and labeling, as required
• Safety review of clinical protocols, IBs, ICFs, and related documents to ensure alignment with safety strategy and risk communication plans
• Accountability for safety components of:
  • Clinical Study Reports (CSRs)
  • Publications
  • Aggregate reports
  • Other regulatory documents
•  Conducting signal detection and evaluation activities for continuous benefit–risk assessment across the product lifecycle
• Supporting implementation of signal evaluation decisions, including updates to core safety information and key safety documents
• Contributing to regulatory filings (NDAs, BLAs) and responses to safety queries from regulatory agencies and third parties
• Establishing and maintaining collaborative relationships with key stakeholders (study teams, CROs, investigators, study sites, vendors, and committees)
• Ensuring compliance with all governing laws, regulations, and standard operating procedures (SOPs)

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Required Skills & Experience
•    3+ years of drug development experience in the pharmaceutical or related industry, including at least 1 year in drug safety
•    Proven ability to build and sustain strong partnerships with internal and external stakeholders
•    Broad understanding of safety science, pharmacovigilance (including GVP and GCP), clinical/patient risk management, and safety operations
•    Demonstrated ability to lead and influence in a fast-paced environment
•    Strong presentation skills and ability to summarize key considerations and decision points
•    Collaborative team mindset with a drive for innovation and continuous improvement
•    Strong attention to detail and ability to prioritize and work independently
•    Strong organizational skills and ability to interpret, discuss, and report trial-level data and identify trends
•    Excellent written and verbal communication skills
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Preferred Skills
•    Independent leadership of drug safety activities for clinical programs, including signal evaluation and benefit–risk assessment
•    Experience authoring and reviewing key safety documents (e.g., DSURs, IB updates, protocol and CSR safety sections)
•    Proven 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 and technologies
•    Therapeutic area experience in oncology
Education
•    Relevant postgraduate qualification (e.g., MD, PharmD, PhD/MSc in Life Sciences, or other postgraduate health professional qualification)

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Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [email protected].