Associate Director, Pharmacovigilance Operations - Cambridge - Relay Therapeutics

    Relay Therapeutics
    Relay Therapeutics Cambridge

    2 days ago

    $145,000 - $207,000 (USD) per year
    Description
    The Opportunity
    The Associate Director, PV Operations is responsible for developing and leading key PSRM
    operational functions, including case management oversight and compliant global ICSR
    and aggregate safety reporting. This role is responsible for oversight of safety operations
    activities including but not limited to collection, management and reporting of SAE and
    other safety information from clinical programs, maintenance and updates to safety
    database and ensuring compliance to Safety Data Agreements and global regulatory
    requirements. The position partners closely with clinical development and program teams
    to guide safety management throughout Relay's portfolio.
    Your Role:
  • Develop and maintain departmental SOPs, work instructions, and guidelines related
    to SAE processing and reporting.
  • Maintain regulatory reporting calendars and global reporting requirement matrices.
  • Create and update study-specific safety management plans in collaboration with
    study teams.
  • Lead SAE-related study start-up activities and oversee CRO case management
    operations, including database maintenance.
  • Oversee timely submission and distribution of expedited safety reports to regulatory
    authorities, investigators, CROs, and partners.
  • Collaborate with data management to develop SAE eCRFs for Relay-sponsored
    studies.
  • Oversee Safety Service Provider-executed safety operations activities related to
    SAE management, ICSR reporting, and aggregate reporting.
  • Develop and maintain safety templates and forms with cross-functional
    stakeholders and CROs.
  • Contribute to safety content in, protocols, CRFs, CSRs and regulatory submissions.
  • Ensure internal personnel are trained in pharmacovigilance principles,
    policies/procedures and external personnel are trained in safety reporting
    requirements & procedures.
  • Manage the Relay safety mailbox.
    • Your Background:
  • Experience in global program support required; experience in oncology programs, is
    preferred.
  • Expertise in case management oversight and global safety reporting compliance.
  • Significant experience with Safety Data Exchange Agreements/Pharmacovigilance
    Agreements and partner management.
  • Demonstrated competency in safety vendor oversight and inspection readiness.
  • Proven ability to manage complex safety data flows and ensure reporting
    compliance.
  • Advanced knowledge of global PV regulations, including US CFR, EU GVP, and ICH
    guidelines.
  • Proficiency with drug safety databases, preferably Argus.
  • Excellent communication skills.
  • Minimum of 6 years of relevant industry experience, including 4 years in drug safety.
  • Healthcare degree: RN or PharmD preferred
    • Estimated Salary Range: [$145,000 - $207,000].
    The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate's education, experience, skills and location.
    #BP1
    About Relay Therapeutics
    Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process.
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