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    Senior Manager/Associate Director, Drug Safety Operations - San Diego, United States - Longboard Pharmaceuticals, Inc.

    Longboard Pharmaceuticals, Inc.
    Longboard Pharmaceuticals, Inc. San Diego, United States

    3 weeks ago

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    Description
    Job Description

    Job Description


    Job Title:
    Senior Manager/Associate Director, Drug Safety Operations

    Reporting To:
    Vice President, Global Regulatory Affairs

    Department :
    R&D: Clinical Development


    People Manage r:
    No


    FLSA Status:
    Exempt

    Location:
    San Diego (hybrid) or remote

    Position Summary

    The Senior Manager/Associate Director, Drug Safety Operations will be responsible for oversight of safety operation activities with vendors and partners, including implementing safety reporting processes, monitoring compliance with internal standard operating procedures, overseeing adverse event case management, oversight of the drug safety database, providing support to study teams and projects.


    Reporting to the Vice President, Global Regulatory Affairs the Senior Manager/Associate Director, Drug Safety Operations will collaborate cross-functionally to support safety activities for clinical trials.

    Responsibilities include but may not be limited to:

    Provide guidance and oversight of safety responsibilities outsourced to safety vendors

    Oversees/ensures safety case queries are resolved as per defined processes (interfacing with clinical operations team and clinical vendors, as required)
    Monitors performance and quality compliance (e.g. quality metrics, other reports) of the safety vendor and the quality output of the ICSRs; provides appropriate feedback and training

    Oversee case workflow (case receipt through submission) between safety vendor and Longboard

    Review incoming adverse events to determine the action required
    Manage preparation and processing of SAE/SUSAR reports activities for all investigational drugs
    Ensures safety cases are closed within required timelines with resolution of required queries
    Ensure corporate compliance with domestic and international adverse event reporting requirements for all products in worldwide development programs

    Operational oversight and execution of operational safety tasks for all clinical programs

    Supports safety data reconciliation activities and ensures safety vendor responsibilities are completed within the required timelines
    Oversee maintenance of safety database for tracking, storing, and reporting serious adverse events from all clinical trials.
    As required, present safety reporting processes according to study protocol at Investigator Meetings or to other required audience.
    Collaborate with partners on the exchange of safety data, safety monitoring, and the safety profile of investigational drugs as defined in Pharmacovigilance Agreements; Monitor partner compliance with partner Safety related activities as per agreement
    Responsible for UAT and Implementation of updates within Safety Database
    Oversee periodic MedDRA and WHO Drug upgrades
    Perform and manage SAE reconciliation between safety and clinical databases
    Collaborate with vendors for TMF Safety documents filing and review

    Contribute to preparation of relevant sections of clinical study reports, annual reports (e.g. DSUR), aggregate reports, expedited safety reports and other regulatory documents

    Oversee submission activities for DSUR, ICSRs and aggregate reports

    Author and maintain SOPs

    as applicable

    Minimum Requirements

    Bachelor's degree in Life Sciences, Healthcare, or relevant field, advanced degree preferred
    5-8 years of progressive experience working in Drug Safety
    Knowledge of and experience with international regulatory adverse event reporting requirements
    Hands-on experience with adverse event case processing
    Experience with Safety Databases (Argus, ArisG or other)
    Previous clinical healthcare experience (e.g. nursing) a plus
    Excellent interpersonal communication skills and ability to work effectively as part of a team

    About Longboard
    At Longboard Pharmaceuticals, our mission is to enhance the lives of individuals battling profound neurological conditions. Collaboratively, we foster an inclusive company culture and an inviting environment that we take immense pride in. We actively seek dynamic, talented, and dedicated individuals to join our team.

    Pay Transparency

    The expected salary for candidates who work in La, Jolla, CA is $150,000.00-$180, The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc.

    Longboard Pharmaceuticals, Inc is a multi-state employer and will consider candidates based in remote work locations.

    Benefits

    At Longboard, we prioritize the well-being and satisfaction of our employees, understanding that benefits play a crucial role in their overall compensation and life quality.

    We take pride in providing a robust suite of benefits designed to safeguard the health and happiness of our team members, their families, and their lifestyles.


    Our benefits currently include:
    Hybrid work schedule out of our La Jolla office, 2-3 days a week
    Competitive compensation package including bonus opportunities and stock options
    Medical, Dental & Vision Plans
    401(k) Plan, including company match with immediate vesting
    Flexible Time Off, including one week off in the summer and one week off around December holidays
    11 paid company holidays per year
    An opportunity to do truly meaningful work to make a lasting impact
    Longboard Perks (on-site gym, garage parking, company-sponsored events, etc.)
    Flexible spending account for medical care
    Life insurance, short and long term disability plans

    #LI-Hybrid #LI-Remote

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