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    Director, Pharmacovigilance

    4d Molecular Therapeutics
    5+ years
    $210,000 - $270,000 per year
    Remote, USA
    10 Oct. 1, 2024
    Job Description
    Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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

    Attention Recruitment Agencies:

    All agency inquiries must go through 4DMT’s internal Talent Acquisition team. We do not accept unsolicited resumes. The Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated and may jeopardize future collaboration with 4DMT.

    About 4DMT

    4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution to develop targeted genetic medicines. Our innovative platform, Therapeutic Vector Evolution (TVE), combines directed evolution with approximately one billion synthetic AAV capsid-derived sequences to create advanced vectors for our products. We aim to treat a wide range of large market diseases, moving beyond the traditional focus on rare conditions typical of many genetic therapies.

    Company Differentiators:

    • Fully integrated clinical-phase company with in-house manufacturing
    • Proven ability to rapidly progress from concept to IND
    • Five candidate products currently in clinical trials, along with two pre-clinical programs
    • Strong technology and intellectual property foundation, including our TVE and manufacturing platforms
    • Initial safety and efficacy data supporting the value of our platforms
    • Opportunities to expand into additional indications and modalities within genetic medicine

    Position: Director of Pharmacovigilance

    Role Summary:

    The Director of Pharmacovigilance will implement and coordinate pharmacovigilance activities for 4DMT products. As a knowledge leader, this position will actively participate in safety-related aspects throughout the product life cycle, from development to post-marketing. The individual will ensure rigorous analysis, informed decision-making, and effective communication of safety information to both internal teams and regulatory authorities. A proactive approach to safety communication and program development is essential.

    This role will interface closely with internal teams, including Clinical Science, Clinical Operations, Regulatory Affairs, and Compliance/Quality. Thorough documentation of safety issue origins, histories, and resolutions will be critical.

    Key Responsibilities:

    • Lead signal detection and assessment activities for 4DMT products, including:
      • Creating signal summary reports
      • Utilizing safety database tools for aggregating data
      • Leading cross-functional teams to evaluate safety signals
      • Developing action plans for risk mitigation
      • Responding to safety-related Health Authority requests
      • Creating and maintaining Product Risk Management Plans (RMP)
    • Monitor the safety profiles of assigned products and recommend necessary actions, including labeling amendments and risk management programs.
    • Prepare safety-related sections for clinical and regulatory documents, including clinical study protocols, IND annual reports, and Investigator Brochures.
    • Review informed consent forms and other study documents containing safety information.
    • Participate in the maintenance and enhancement of pharmacovigilance processes, including MedDRA maintenance and implementation of new regulations.
    • Ensure compliance with domestic and international adverse event reporting requirements.
    • Supervise pharmacovigilance activities related to licensing partners and CROs.
    • Collaborate with training teams to provide guidance on safety compliance and best practices.
    • Serve as a safety liaison on clinical study project teams.
    • Engage with service providers to address safety queries and discuss new safety regulations.

    Qualifications:

    • MD, PharmD, RN, BSN, Nurse Practitioner, Pharmacist, or related degree with at least 5 years of experience in the pharmaceutical industry, focusing on safety surveillance or applicable clinical/medical experience.
    • Strong knowledge of domestic and international adverse event reporting regulations.
    • Proficiency with drug safety databases (e.g., ARISg or ARGUS).
    • Excellent oral and written communication skills, with strong interpersonal abilities and a collaborative mindset.
    • Highly organized with the ability to prioritize workflows and manage multiple tasks under pressure.
    • Strong understanding of clinical trial methodology, GCP, and medical terminology.
    • Attention to detail and quality-focused, with strong problem-solving skills.
    • Excellent organizational and project management skills.
    • Proficient in creating spreadsheets, templates, and presentations, as well as working with safety database applications.

    Compensation Range: $210,000 - $270,000 per year

    Please note that the final salary offered will depend on factors such as geographical location, relevant work experience, skills, and years of experience.

    4DMT is an equal opportunity employer, committed to fostering an inclusive environment for all employees and applicants, regardless of race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, veteran status, or any other category protected by applicable laws.

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