Safety System Manager, Argus SME

Fortrea; Maharashtra; On-site; INR 1,800,000 - 3,600,000; Full time

Job summary

Fortrea is seeking a PV systems expert to support the Safety system implementation, migration, and ongoing operation. The role involves driving IT system strategy, ensuring regulatory compliance, and delivering high-quality, compliant safety system solutions.

You will collaborate with stakeholders, lead training, and manage end-to-end release cycles while maintaining SOPs and industry standards.

Qualifications

• Experience in systems operations support role.
• Experience working on validated document management systems.
• Fortrea may consider relevant and equivalent experience.
• Good working knowledge of Microsoft Office tools.
• System integration knowledge.
• Required Skills- Change Management, CRM, people management, Vendor Management.

Responsibilities

• PV systems expert responsible for leveraging a strong combination of business and technical knowledge.
• 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.
• Independently driving meetings and developing the IT system strategy, Compliance management, periodic System Evaluation, reviewing Enterprise Architecture of the system.
• Support and educate end users and sponsors, if applicable.
• Collaborate with training team in development of safety system specific training module.
• 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 all data migration activities and documentation related to migration.
• Support with change management and training of the systems, as needed.
• Respond to mailbox queries.
• Train team members on technical and functional aspects.
• Completing work assignments to the highest quality standards, adhering to relevant SOPs, and keeping up to date with knowledge of current PV regulations.
• Making updates to Departmental Standard Operating Procedures, Working Practices and Guidelines.
• Monitor the mailbox for system failures to resolve them promptly.
• Subject matter expert, looking for ways to improve compliance, quality, and efficiency.
• Perform User Acceptance Testing and complete required documentation.
• Lead critical team projects, responsible for managing team’s workload.
• Monitors staff projects quality, timelines, and budgets to foresee and correct issues and assure project expectations are met.
• Help staff identify resource or scope of work changes.
• Effectively communicate the status of projects to line management and project managers.
• Manages discretionary expenses and spending within team to meet budget.
• Working closely with leads to ensure that staff resources are used efficiently, and the team is well utilized.
• Manages resources within team: new hires, terminations, transfers, and contractors.
• Carry out line management responsibilities for assigned staff, including Performance Management and Development activities, disciplinary procedures, and administrative activities.
• Helps encourage staff career growth and development.
• Provides system support and technical support to team members.
• Act as the lead overseeing technical planning for increasingly complex projects including global and multiple study projects and electronic submissions.
• Representing Systems team at internal project team meetings, client meetings and audits.
• Contribute to ongoing improvement of programming processes, methodology and documentation.
• Facilitate advanced technical expertise, share knowledge at department meetings.
• Keeps abreast of new Safety system practices, methods and tools, regulatory practices, and industry trends to stimulate departmental growth.
• Responsible for taking care of Project management activities and working on Client communications.
• Collaborating closely with the key stakeholders including follow-up on vendor deliverables and service according to agreements.
• Carry out end to end release management cycle of the IT System.
• Responsible for the operation and maintenance of critical IT systems located and used in
• Managing stakeholder and vendor activities.
• And all other duties as needed or assigned.

Skills

Change Management

CRM

People management

Vendor Management

Education

Life Science or IT/computing degree

Tools

Argus

ARISg

Veeva

Job description

• Assist with the overall Safety system implementation, support, configuration, and Migration

Job Overview

• Assist with the overall Safety system implementation, support, configuration, and Migration

related activities.

• Responsible for providing this service to clients either as a support function to the client project

groups or as stand- alone business.

• Responsible for providing all clients, both internal and external, with the appropriate quality of

service in a safe and cost-effective manner.

• Candidate will be expected to comply with the legal requirements of the Health & Safety at

Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives

1992/3 as documented in the Company’s Health & Safety Manual.

Summary Of Responsibilities

List Of All Responsibilities, Skills, And Duties.

• PV systems expert responsible for leveraging a strong combination of business and technical

knowledge.

• 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.
• Independently driving meetings and developing the IT system strategy, Compliance

management, periodic System Evaluation, reviewing Enterprise Architecture of the system.

• Support and educate end users and sponsors, if applicable.
• Collaborate with training team in development of safety system specific training module

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 all data migration activities and documentation related to migration.
• Support with change management and training of the systems, as needed.
• Respond to mailbox queries.
• Train team members on technical and functional aspects.
• Completing work assignments to the highest quality standards, adhering to relevant SOPs, and

keeping up to date with knowledge of current PV regulations.

• Making updates to Departmental Standard Operating Procedures, Working Practices and

Guidelines.

• Monitor the mailbox for system failures to resolve them promptly.
• Subject matter expert, looking for ways to improve compliance, quality, and efficiency.
• Perform User Acceptance Testing and complete required documentation.
• Lead critical team projects, responsible for managing team’s workload.
• Monitors staff projects quality, timelines, and budgets to foresee and correct issues and assure

project expectations are met.

• Help staff identify resource or scope of work changes.
• Effectively communicate the status of projects to line management and project managers.
• Manages discretionary expenses and spending within team to meet budget.
• Working closely with leads to ensure that staff resources are used efficiently, and the team is

well utilized.

• Manages resources within team: new hires, terminations, transfers, and contractors.
• Carry out line management responsibilities for assigned staff, including Performance

Management and Development activities, disciplinary procedures, and administrative activities.

• Helps encourage staff career growth and development.
• Provides system support and technical support to team members.
• Act as the lead overseeing technical planning for increasingly complex projects including global

and multiple study projects and electronic submissions.

• Representing Systems team at internal project team meetings, client meetings and audits.
• Contribute to ongoing improvement of programming processes, methodology and

documentation.

• Facilitate advanced technical expertise, share knowledge at department meetings.
• Keeps abreast of new Safety system practices, methods and tools, regulatory practices, and

industry trends to stimulate departmental growth.

• Responsible for taking care of Project management activities and working on Client

communications.

• Collaborating closely with the key stakeholders including follow-up on vendor deliverables and

service according to agreements.

• Carry out end to end release management cycle of the IT System.
• Responsible for the operation and maintenance of critical IT systems located and used in
• Managing stakeholder and vendor activities.
• And all other duties as needed or assigned.

Qualifications(Minimum Required)

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

management, Vendor Management.

Experience (Minimum Required)

• 10+ years of experience with drug safety systems such as Argus/ARISg/Veeva.
• Good team player and offer peer support as needed.
• Ability to set priorities and handle multiple tasks.
• Attention to detail.
• Good written and verbal communication skills.
• Logical and spelling skills, preferably with an aptitude for handling and proof-reading numerical

data.

Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.

Ability to operate standard office equipment.

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