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    Medical Director Gps Us - Remote Opportunity

    Lundbeck
    5+ years
    $240,000 - $280,000
    Remote, USA
    10 July 22, 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

    Medical Director, GPS - Remote Opportunity

    Location: Deerfield, Illinois, US
    Requisition ID: 5424
    Remote Opportunity: Open to candidates across the greater United States

    About Lundbeck: At Lundbeck, our mission is to restore brain health so every person can be their best. As the only global biopharmaceutical company dedicated solely to brain diseases, we are committed to delivering transformative therapies in neurology and psychiatry. Join us in our journey of growth and make a meaningful impact!

    Role Overview: We are seeking a Medical Director for our Global Patient Safety (GPS) team. This role involves monitoring the safety profile of Lundbeck products in accordance with FDA and global Pharmacovigilance guidelines. The ideal candidate will have significant experience with 'Big Data' analysis, a strong grasp of global PV regulations, and the ability to leverage real-world data to enhance pharmacovigilance activities.

    Key Responsibilities:

    • Medical Review and Assessment: Ensure the medical accuracy, completeness, and quality of Individual Case Safety Reports (ICSRs). Instruct staff on follow-up procedures.
    • Aggregate Reports: Review safety profiles and risk/benefit ratios for Lundbeck products, ensuring scientific accuracy and detailed content for aggregate reports.
    • Signal Management: Develop and implement strategies for signal detection and safety data generation. Communicate findings internally and externally, and present to safety governance bodies.
    • Risk Management: Oversee risk management activities, including REMS programs, and develop risk minimization strategies. Act as the subject matter expert during inspections and audits.
    • Other Deliverables: Chair safety committees, provide medical safety input for pharmacoepidemiology studies, and respond to safety-related inquiries from health authorities.

    Required Education, Experience, and Skills:

    • Accredited MD/DO (MBBS, MBCHb, MBBCh).
    • 5+ years of drug safety experience in a biotech or pharmaceutical setting.
    • Strong analytical skills and experience with 'Big Data' and signal detection methodologies.
    • Extensive knowledge of pharmacovigilance regulations and risk management strategies.
    • Ability to work independently in a fast-paced environment with excellent communication skills.

    Preferred Qualifications:

    • 2+ years of clinical practice experience in CNS Therapeutic Areas (Psychiatry or Neurology).
    • 10+ years of drug safety experience.
    • Advanced degree in Epidemiology or Master of Public Health (MPH).

    Travel Requirements:

    • Willingness to travel up to 5% domestically; international travel may be required.

    Compensation:

    • Salary range: $240,000 - $280,000, with a 25% bonus target based on performance and eligibility for the company's long-term incentive plan. Benefits include flexible paid time off (PTO), health benefits, and a 401k match.

    Why Lundbeck? Lundbeck offers a comprehensive benefits package and is committed to creating an inclusive workplace. We provide reasonable accommodations for disabled veterans and individuals with disabilities during the application process. Lundbeck is an equal opportunity employer, and we participate in E-Verify.

    Apply Today: Applications are accepted on an ongoing basis. For more information about our benefits and to apply, visit our U.S. career site.

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