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    Associate Director Of Icsr (Europe)

    Primevigilance
    6-7 years
    Not Disclosed
    Bucharest
    10 Dec. 5, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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 Director of ICSR (Europe)
    Company: PrimeVigilance (part of Ergomed PLC)
    Location: Remote
    Employment Type: Full-time

    Company Overview:

    PrimeVigilance, part of Ergomed PLC, is a specialized pharmacovigilance service provider established in 2008. With a focus on Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance, PrimeVigilance has grown organically and provides services to pharmaceutical and biotechnology partners globally, covering all therapy areas, including medical devices. The company places a high value on its employees, investing in their training and development, while fostering a culture that emphasizes work-life balance, mental health, and employee well-being.

    Job Description:

    The Associate Director of ICSR (Europe) will manage the ICSR Management Unit, ensuring high-quality delivery of pharmacovigilance activities while contributing to the company’s goals and objectives. This role involves resource and productivity management, budgeting, and coordinating with other departments.

    Key Responsibilities:

    • Manage the ICSR Management Unit to ensure high performance and resource utilization.
    • Set productivity targets for projects and monitor progress.
    • Reallocate resources based on workload analyses to maximize productivity and efficiency.
    • Supervise ICSR Leads/Line Managers, ensuring they manage resources effectively and are meeting productivity targets.
    • Coordinate with the Resourcing department to request additional resources when needed for project teams.
    • Identify best practices to improve efficiency and propose changes within project teams.
    • Train and mentor senior staff and ICSR Line Managers.
    • Review budgets for new projects and updates to existing projects, ensuring alignment with resources.
    • Assist the Business/Commercial team in contract and proposal development.
    • Support HR in activities related to recruitment, performance evaluations, promotions, and terminations.
    • Approve Critical CAPAs and address any requests from the Quality department related to ICSR processes.
    • Review and update operational procedures as required.
    • Support the RA & PV Network Department as needed, including roles like Local Contact Person for Pharmacovigilance (LCPPV) and Person Responsible for Local Screening (PRLS).

    Qualifications:

    • Education: Life science graduate, pharmacy, nursing, or other healthcare-related qualification.
    • Experience:
      • 6-7 years of work experience in pharmacovigilance.
      • 2-3 years of experience in a line manager role.
    • Special Skills:
      • Strong communication skills (written and verbal).
      • Excellent organizational, delegation, and management skills.
      • Attention to detail, multitasking, and ability to meet deadlines.
      • Technical proficiency in tools like MS Office.
      • Ability to work effectively within a team.
    • Language Skills: Fluent in English (spoken and written, Full Professional proficiency).

    Why PrimeVigilance?

    PrimeVigilance is committed to creating a diverse, equitable, and inclusive work environment. The company offers:

    • Competitive salary.
    • Opportunities for career growth within a dynamic team.
    • Multicultural environment with English as the company language.
    • Focus on personal and professional development, including specialized training in pharmacovigilance.
    • Friendly working environment with regular social events.

    Core Values:

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

    If these values resonate with you, PrimeVigilance could be the right company to join.

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