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Safety Systems Associate Manager

Safety Systems Associate Manager

Fortrea Development India Private Limited
4-8 Years
Not Disclosed
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Job Description

 Responsibilities:

The statements below are intended to describe the job's general nature and not to be an exhaustive list of all responsibilities, skills, and duties.

  • PV systems expert responsible for leveraging a strong combination of business and technical knowledge.
  • Conduct and oversee project specific configurations in safety systems.
  • Evaluate proposed project ideas / software changes through technical impact analysis and estimated business value to contribute to decision-making.
  • Develop and document standard and ad hoc reports from the safety systems.
  • Support and educate end users and sponsors, as applicable.
  • Collaborate with training team in development of safety system specific training modules.
  • Initiate discussions with business stakeholders to understand business requirements, document user requirements and ensure requirements are delivered on time and in collaboration with Tech partner.
  • Provide overall guidance and strategize use of standard safety systems front-end reporting including use of advanced conditions and Standard MedDRA Queries (SMQ).
  • Actively participate in and oversee data migration activities and documentation related to migration.
  • Expertise in Ticket management, issue resolution and escalating system issues where applicable.
  • Making updates to Departmental Standard Operating Procedures, Working Practices and Guidelines.
  • Monitor the mailbox for system failures to resolve them promptly and manage vendor queries.
  • Subject matter expert, looking for ways to improve compliance, quality, and efficiency.
  • Perform and review User Acceptance Testing and complete required documentation.
  • Lead critical team projects and are responsible for project deliverables within budget.
  • Monitor staff project quality, timelines, and budgets to foresee and correct issues and assure project expectations are met.
  • Effectively communicate the status of projects to line management and project managers.
  • Carry out team development responsibilities including mentoring, and administrative activities.
  • Support to new hires, onboarding, transfers, and contractors, in coordination with the reporting manager.
  • Representing the Systems team at internal project team meetings, client meetings and audits.
  • Contribute to the ongoing improvement of programming processes, methodology and documentation.
  • Collaborate closely with key stakeholders including follow-up on vendor deliverables and service according to agreements.
  • And all other duties as needed or assigned.

 

Qualifications (Minimum Required):

  • Life Science or IT/computing degree.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
  • Experience in systems operations support role.
  • Experience working on any validated document management systems.
  • Good working knowledge of Microsoft office tools.
  • System integration knowledge.
  • Required Skills – Project Management, Change Management, Customer Relationship Management (CRM), and Vendor Management.

 

More Info

Job Type:
Function:
Employment Type:

Key Skills

Pharmacovigilance (PV) Safety Systems Management

Drug Safety Systems Configuration (Argus/ARISg/Veeva)

Data Migration & System Integration

User Acceptance Testing (UAT) & Regulatory Compliance

Project & Change Management