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Safety Systems Associate Manager
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Safety Systems Associate Manager
Fortrea Development India Private LimitedEarly Applicant
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- Posted 7 hours ago
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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
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
