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    Senior Manager/Associate Director, Drug Safety Operations

    Longboard Pharmaceuticals
    5-8 years
    $150,000.00-$180,000.00
    Remote, USA
    10 July 29, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Senior Manager/Associate Director, Drug Safety Operations
    Reporting To: Vice President, Global Regulatory Affairs
    Department: R&D: Clinical Development
    People Manager: No
    FLSA Status: Exempt
    Location: San Diego (hybrid) or remote

    Position Summary:
    The Senior Manager/Associate Director, Drug Safety Operations, is responsible for overseeing safety operations activities with vendors and partners. This includes implementing safety reporting processes, monitoring compliance with internal SOPs, overseeing adverse event case management, managing the drug safety database, and supporting study teams and projects. Reporting to the Vice President, Global Regulatory Affairs, this role collaborates cross-functionally to support safety activities for clinical trials.

    Key Responsibilities:

    • Provide guidance and oversight for safety responsibilities outsourced to vendors.
    • Resolve safety case queries in collaboration with clinical operations and vendors.
    • Monitor and ensure quality compliance of the safety vendor's outputs, providing feedback and training.
    • Oversee the case workflow from receipt to submission with safety vendors.
    • Review adverse event reports and determine necessary actions.
    • Manage SAE/SUSAR reporting activities for investigational drugs.
    • Ensure timely resolution and closure of safety cases.
    • Ensure compliance with domestic and international adverse event reporting requirements.
    • Oversee operational safety tasks for clinical programs.
    • Support safety data reconciliation activities and ensure vendor compliance.
    • Maintain the safety database for tracking and reporting serious adverse events.
    • Present safety reporting processes at Investigator Meetings or to other audiences as needed.
    • Collaborate with partners on safety data exchange and monitoring, ensuring compliance with Pharmacovigilance Agreements.
    • Manage UAT and implementation of updates within the Safety Database.
    • Oversee periodic MedDRA and WHO Drug upgrades.
    • Perform SAE reconciliation between safety and clinical databases.
    • Collaborate with vendors on TMF Safety documents filing and review.
    • Contribute to the preparation of clinical study reports, DSURs, aggregate 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 a relevant field; advanced degree preferred.
    • 5-8 years of progressive experience in Drug Safety.
    • Knowledge of international regulatory adverse event reporting requirements.
    • Hands-on experience with adverse event case processing.
    • Experience with Safety Databases (Argus, ArisG, or similar).
    • Previous clinical healthcare experience (e.g., nursing) is a plus.
    • Excellent interpersonal communication skills and team collaboration ability.

    About Longboard Pharmaceuticals:
    Longboard Pharmaceuticals is dedicated to improving the lives of individuals with profound neurological conditions. We cultivate an inclusive company culture and welcoming environment, and we're always looking for dynamic, talented, and dedicated individuals to join our team.

    Pay Transparency:
    The expected salary range for candidates in La Jolla, CA, is $150,000.00-$180,000.00. The final salary offered will depend on various factors, including experience, education, and more. Longboard Pharmaceuticals, Inc is a multi-state employer and will consider candidates from remote locations.

    Benefits:
    At Longboard, we prioritize our employees' well-being and satisfaction, offering a comprehensive benefits package to support their health, happiness, and lifestyle. Our benefits include:

    • Hybrid work schedule (2-3 days a week in our La Jolla office)
    • Competitive compensation package with bonus opportunities and stock options
    • Medical, Dental & Vision plans
    • 401(k) Plan with company match and immediate vesting
    • Flexible Time Off, including a week off in the summer and during the December holidays
    • 11 paid company holidays per year
    • Opportunities to do meaningful work with 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

    Join Longboard Pharmaceuticals and make a meaningful impact on patients' lives.

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