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    System Support Specialist

    Primeforce Solutions
    1-2 years
    Not Disclosed
    10 May 15, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: System Support Specialist

    Essential Job Functions:

    1. Management of System Access and Permissions:

      • Administer system access and permissions for users.
      • Ensure compliance with security protocols and regulatory requirements.

    2. Change Management Activities:

      • Facilitate change management processes for system modifications and updates.
      • Coordinate with stakeholders to implement changes effectively.

    3. Technical Issue Resolution:

      • Address and resolve technical issues related to system functionality.
      • Provide troubleshooting support to users.

    4. Report Creation:

      • Generate reports as required by stakeholders.
      • Customize reports to meet specific business needs.

    5. User Training Support:

      • Assist in providing user training for system functionalities.
      • Support users in navigating and utilizing the system effectively.

    6. System Documentation Maintenance:

      • Maintain up-to-date documentation for system configurations and processes.
      • Ensure accuracy and completeness of system documentation.

    7. Standard Operating Procedure (SOP) Development:

      • Author and develop SOPs and work instructions for application support and maintenance.
      • Ensure SOPs are compliant with regulatory standards.

    Core Competencies, Knowledge, and Requirements:

    • Experience:
      • Minimum 2 years of experience supporting systems, specifically Veeva Vault - RIMS/eTMF.
      • At least 1 year of experience with validated applications in a pharmaceutical or regulated environment.
    • System Administration:
      • Proficiency in system administration of GxP applications.
      • Familiarity with Quality Document Management System and Regulatory Information Management system.
    • Technical Skills:
      • Basic knowledge of databases, SQL, and computer networking.
      • Experience with Software-as-a-Service (SaaS) systems such as Veeva Quality, RIM, PromoMats, and MedComms is desirable.
      • Basic programming or scripting knowledge (e.g., Python, Java) is a plus.
    • Interpersonal and Communication Skills:
      • Excellent interpersonal, communication, analytical, and organizational skills.
      • Skilled in conflict resolution and negotiation, fostering open communication.
    • Teamwork and Problem-Solving:
      • Ability to work collaboratively in a team environment.
      • Capable of managing multiple systems and complex timelines.
      • Effective problem-solving and troubleshooting skills, especially under pressure.
    • Independence and Time Management:
      • Ability to work independently under general supervision.
      • Strong prioritization skills to handle multiple projects simultaneously.
    • Global Environment Adaptability:
      • Experience working in a global environment across multiple time zones.
      • Effective communication of project expectations to team members and stakeholders.

    This role requires a candidate with strong technical skills, regulatory compliance knowledge, and the ability to effectively collaborate in a team setting to support critical systems within a regulated environment.

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