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    Associate Director Of Icsr (Europe)

    Primevigilance
    6-7 years
    Not Disclosed
    Remote - Europe
    10 Oct. 17, 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

    Associate Director of ICSR (Europe)

    Employees can work remotely
    Full-time
    Department: ICSR Management

    Company Description

    We are PrimeVigilance, part of Ergomed PLC, a specialized mid-sized pharmacovigilance service provider established in 2008. We are proud of our consistent global organic growth, with staff across Europe, North America, and Asia providing services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

    PrimeVigilance offers first-class support to our pharmaceutical and biotechnology partners, fostering long-lasting relationships and establishing ourselves as global leaders in the field. We cover all therapy areas, including medical devices.

    We are committed to investing in our employees through excellent training and development programs. We value employee experience, well-being, and mental health, recognizing that a healthy work-life balance is crucial for satisfaction and high-quality client service.

    Job Description

    Position Summary:
    Manage the ICSR Management Unit for assigned staff and ensure all unit-relevant activities are delivered within agreed parameters. Contribute to achieving the company’s goals and objectives through project budget reviews and management support for ICSR leads. Responsibilities include independent analysis of workload, productivity, and resource utilization to ensure optimal performance and coordination with other departments.

    Role and Responsibilities:

    • Effectively manage the assigned ICSR Management Unit.
    • Ensure adequate resources within ICSR project teams to maximize productivity and utilization.
    • Set productivity targets for ongoing projects and review proposed target updates.
    • Define appropriate resource reallocation based on reports and analyses, collaborating with the resourcing unit as needed.
    • Manage ICSR Leads/Line Managers to ensure optimal employee utilization and productivity.
    • Notify the Resourcing department of the need for additional resources when internal management is insufficient.
    • Propose necessary changes to project team processes to ICSR leadership.
    • Identify solutions and introduce best practices to enhance productivity within the ICSR Management Unit.
    • Train and mentor ICSR Line Managers and senior staff.
    • Prepare various analyses and reports.
    • Review budgets and resource allocations for new projects and changes to existing scopes of work.
    • Support the Business/Commercial team in developing contracts and proposals.
    • Assist Operations and Project Analytics teams as needed.
    • Collaborate with HR on recruitment, performance evaluations, promotions, retention, and terminations.
    • Review and approve all Critical CAPAs from the ICSR Management Unit.
    • Address any requests from the Quality department regarding ICSR Management Unit operations.
    • Review and update PrimeVigilance operating procedures and guidelines as applicable.
    • Support the RA & PV Network Department, including acting as the Local Contact Person for Pharmacovigilance and the Person Responsible for Local Screening for designated languages.

    Qualifications

    • Education: Life science graduate, pharmacy, nursing, or other healthcare-related qualification or experience in pharmacovigilance.
    • Experience: 6-7 years in pharmacovigilance, including 2-3 years in a line manager role.
    • Special Skills:
      • Excellent written and verbal communication skills.
      • Strong organizational skills with attention to detail and multitasking ability.
      • Effective management skills, including delegation, time, and issue management.
      • Technical skills and team collaboration.
    • Language Skills: Fluent English (spoken and written).
    • PC Skills: Advanced literacy in MS Office.

    Additional Information

    We prioritize diversity, equity, and inclusion by fostering an equal-opportunity workplace where individuals of all cultural backgrounds, genders, and ages can contribute and grow.

    To succeed, we must work together with a human-first approach. Our people are our greatest strength, driving our success in improving lives.

    Our Offer:

    • Competitive salary.
    • A dynamic team in a fast-growing company with opportunities for quick career growth.
    • A multicultural environment with English as the company language.
    • Strong emphasis on personal and professional development.
    • Extensive training in pharmacovigilance, including internal and prestigious seminars abroad.
    • A friendly working environment with several social events throughout the year.

    If our core values resonate with you, PrimeVigilance could be a great fit!

    • Quality
    • Integrity & Trust
    • Drive & Passion
    • Agility & Responsiveness
    • Belonging
    • Collaborative Partnerships

    We look forward to welcoming your application!

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