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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.