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    Associate Director, Safety Scientist

    Beigene
    5+ years
    $150,200.00 - $200,200.00
    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

    Associate Director, Safety Scientist at BeiGene

    BeiGene is experiencing rapid growth and offers challenging and exciting opportunities for experienced professionals. We seek highly motivated and collaborative individuals who share our passion for combating cancer. As a key member of our team, you will leverage your clinical and scientific expertise to advance our mission.

    Position Overview

    The Associate Director, Safety Scientist is instrumental in supporting assigned compounds alongside Product Safety Leads (PSLs). This role involves signal detection, safety data evaluation, risk assessment, regulatory responses, and periodic reporting. You will apply prioritization, critical thinking, and judgment-based decision-making to deliver these key responsibilities in compliance with global regulations and internal processes. Effective communication and influence with internal and external stakeholders are crucial.

    Primary Responsibilities

    Signal and Safety Data Evaluation

    • Lead the identification, analysis, and evaluation of safety data for signal detection from all sources.
    • Conduct signal detection and assessment following BeiGene’s processes.
    • Develop and implement data acquisition strategies for safety evaluations.
    • Analyze safety data and author comprehensive safety assessments.
    • Collaborate with PSLs, Safety Scientists, Pharmacoepidemiologists, and other team members for thorough safety data evaluation.
    • Present safety data at governance meetings and contribute to safety management presentations.
    • Communicate relevant safety information to core teams, business partners, and stakeholders.
    • Develop, update, and review safety communication documents, including Investigator Letters, Informed Consent Forms, and Risk Management Plans.

    Clinical Trial Support

    • Oversee safety data review and patient safety monitoring for clinical trials.
    • Author and review safety sections of development documents and respond to ad-hoc safety queries.
    • Contribute to regulatory submissions and safety management plans.
    • Provide training for investigators on Safety Science specifics.

    Risk Assessment, Regulatory Inquiries, and Periodic Reporting

    • Analyze safety data and author sections of global regulatory inquiries and periodic reports (e.g., DSURs, PADERs, PSURs).
    • Support health authority evaluations and responses to safety-related questions.
    • Contribute to integrated Benefit/Risk assessments and Health Hazard Evaluations.

    Promotion and Advancement

    • Influence internal and external stakeholders on pharmacovigilance principles.
    • Participate in employee development programs and provide Safety Science training.
    • Ensure compliance with internal processes and regulatory requirements.

    Supervisory Responsibilities

    • No direct reports. Collaborate closely with the Safety Science group as part of a matrix team.

    Qualifications

    • Education: PharmD, NP, RN, or PhD in a medical field or biological science with 6+ years of experience in Safety (Pharmacovigilance) Science. Alternatively, an MD or equivalent with accredited residency and 4+ years of clinical experience, including 2+ years in Safety Science, Clinical Development, or Clinical Research.
    • Experience: Proficiency in safety databases (e.g., Argus), MedDRA, and signal management systems. Experienced in pharmaceutical product development and global regulatory requirements for pharmacovigilance.
    • Skills: Advanced application of Excel, PowerPoint, Word, and document management systems. Proficiency in data mining tools such as Spotfire and PowerBI.

    Additional Information

    • Travel: Less than 10%.
    • Salary Range: $150,200 - $200,200 annually. Compensation packages vary based on factors such as skills, experience, education, and location.
    • Benefits: Comprehensive package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. Opportunities for discretionary equity awards and participation in the Employee Stock Purchase Plan.

    BeiGene is an equal opportunity employer, valuing diversity and making employment decisions based on qualifications, merit, and business need. For more details on the salary range and benefits, please consult with the recruiter during the hiring process.

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