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    Associate Director Of Icsr (Europe)

    Primevigilance
    6-7 years
    Not Disclosed
    Remote, USA
    10 Nov. 25, 2024
    Job Description
    Job Type: Full Time 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

    Company Description:
    We are PrimeVigilance, part of Ergomed PLC, a specialized mid-sized pharmacovigilance service provider established in 2008. With global growth across Europe, North America, and Asia, we provide services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

    Our team offers first-class support to pharmaceutical and biotechnology partners, forming long-lasting relationships, and becoming a global leader in the industry. We cover all therapy areas, including medical devices.

    We prioritize employee development, mental health, and work-life balance to ensure high-quality service delivery. Join us to make a positive impact on patient lives!

    Job Description:
    Position Summary:
    We are seeking a Management Lead for the ICSR Management Unit to oversee staff and ensure the effective delivery of all unit-relevant activities. The role involves supporting the achievement of company goals and objectives, conducting project budget reviews, and leading ICSR leads. Key responsibilities include managing workload, analyzing productivity, reallocating resources as needed, and collaborating with other departments to ensure optimal performance.

    Role and Responsibilities:

    • Manage the ICSR Management Unit effectively to ensure high productivity and utilization.
    • Set and review productivity targets for ongoing projects and update them as required.
    • Analyze reports to make informed decisions on resource reallocation within the unit or across departments.
    • Oversee ICSR Leads/Line Managers, ensuring staff are utilized effectively and productively.
    • Request additional resources from the Resourcing Department if needed for project teams.
    • Propose improvements to ICSR team processes and introduce best practices to enhance productivity.
    • Provide training and mentoring to ICSR Line Managers and senior staff.
    • Prepare and review analyses and reports on unit performance.
    • Support budget reviews for new and ongoing projects, collaborating with Directors of Projects as needed.
    • Assist the Business/Commercial team in contract development and proposals.
    • Collaborate with Operations and Project Analytics teams.
    • Assist HR in recruitment, performance evaluation, and retention activities.
    • Oversee and approve all Critical CAPAs from the ICSR Management Unit.
    • Address Quality department requests related to the unit.
    • Support the RA & PV Network Department, including acting as LCPPV (Local Contact Person for Pharmacovigilance) and PRLS (Person Responsible for Local Screening) as assigned.

    Qualifications:

    • Education: Life science graduate, pharmacy, nursing, or equivalent experience in pharmacovigilance.
    • Experience: 6-7 years in pharmacovigilance, including 2-3 years in a line manager role.
    • Skills:
      • Excellent communication (written and verbal) and organization skills.
      • Strong management skills, including delegation, time management, and issue resolution.
      • Proficient in MS Office (Advanced).
      • Teamwork and technical expertise in pharmacovigilance.

    Language Skills:

    • English – fluent (spoken, written).

    Additional Information:
    At PrimeVigilance, we prioritize diversity, equity, and inclusion, creating an equal opportunity workplace where all individuals can grow.

    Our human-first approach ensures our people are our greatest strength, driving success and improving lives.

    Our Offer:

    • Competitive salary and career growth opportunities in a fast-growing company.
    • Multicultural environment with English as the company language.
    • Professional growth with extensive specialized pharmacovigilance training.
    • Friendly working environment and social events throughout the year.

    If our core values resonate with you, PrimeVigilance could be a great place for you to grow and thrive.

    We look forward to welcoming your application!

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