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    Associate Medical Director (Pv Medical Group)

    Primevigilance
    7+ years
    Not Disclosed
    Remote, USA
    10 Nov. 19, 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, 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

    Job Title: Associate Medical Director

    Company Description: PrimeVigilance, a part of Ergomed PLC, is a specialized mid-size pharmacovigilance service provider founded in 2008. With a global presence across Europe, North America, and Asia, we offer services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. Our expertise spans all therapy areas, including medical devices, and we provide first-class support to pharmaceutical and biotechnology partners of all sizes, maintaining long-lasting relationships.

    We are committed to investing in our staff by offering excellent training and development opportunities. We prioritize employee well-being and work-life balance, recognizing their critical role in fostering a high-quality client service environment.

    Job Description: We are seeking an experienced Associate Medical Director to work with the Head of Medical Operations/Medical Director. This leadership role involves overseeing and managing pharmacovigilance physicians and ensuring high standards of quality, compliance, and efficiency in physician activities across client projects.

    Key Responsibilities:

    • Assign PV physicians to client projects, ensuring adequate physician resources and their qualifications.
    • Oversee the integration, analysis, and interpretation of safety information from preclinical to post-marketing stages, including reviewing individual case safety reports, signal detection, aggregate report reviews, and risk/benefit analysis.
    • Provide expert safety input to clinical development programs and trials.
    • Maintain strong client relationships and ensure consistent high-quality work for each client.
    • Attend client meetings to present and discuss safety data.
    • Review or draft responses to drug safety matters from Competent Authorities.
    • Participate in the development and review of Risk Management Plans, Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and other aggregate reports.
    • Lead Drug Safety Review Committee meetings for signal detection and risk evaluation.
    • Oversee a team of pharmacovigilance physicians, ensuring timely and quality deliverables.
    • Support quality and efficiency strategies and manage key performance indicators.
    • Develop risk-based assessments and mitigation plans within the medical department.
    • Ensure appropriate escalation and resolution of potential quality issues.
    • Support the Business/Commercial team with pharmacovigilance medical aspects of contract and proposal development.
    • Attend bid defense meetings and conferences as the medical expert.
    • Deliver pharmacovigilance medical training and oversee the development of physician expertise.

    Qualifications:

    • Medically qualified as a physician; ideally with a higher qualification or postgraduate qualification relevant to pharmacovigilance or pharmacoepidemiology.

    Why Join PrimeVigilance? At PrimeVigilance, we promote diversity, equity, and inclusion, fostering a human-centric workplace where all individuals, regardless of background, can thrive. Our people are our greatest strength, driving our success in improving patients’ lives.

    We Offer:

    • Internal training and career development opportunities.
    • Strong focus on personal and professional growth.
    • A supportive and friendly working environment.
    • Opportunities to collaborate with colleagues globally, with English as the company language.

    If our core values resonate with you, PrimeVigilance could be an excellent place for you to grow. Join us in making a positive impact on patient lives. We look forward to welcoming your application!

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