Safety Systems Associate Manager

Fortrea Development India; Bengaluru; On-site; INR 1,800,000 - 2,900,000; Full time

Job summary

Fortrea Development India is seeking a seasoned professional to support and lead safety system implementations, configurations, and migrations. You will work with clients and internal teams to ensure high-quality, compliant service and oversee end-to-end project delivery.

The role requires experience with Argus/ARISg/Veeva, strong project management, and the ability to document requirements and reports. Office-based with potential travel and collaboration across teams.

Qualifications

• Life Science or IT/computing degree is required or equivalent experience.
• Experience in systems operations support role.
• Experience with validated document management systems.
• Proficient with Microsoft Office tools.
• System integration knowledge.
• Experience with project management, change management, CRM, and vendor management.

Responsibilities

• Assist with overall safety system implementation, configuration, and migration activities.
• Provide service to clients as a support function or stand‑alone business.
• Ensure high quality, safe, cost‑effective service for internal and external clients.
• Supervise and manage projects, ensuring quality, compliance, and timely delivery.
• Comply with Health & Safety regulations and company safety manuals.
• Develop and document standard and ad hoc reports from safety systems.
• Educate end users and sponsors; collaborate with training teams.
• Lead discussions with stakeholders to document and deliver requirements.
• Oversee data migration activities and related documentation.
• Manage ticketing, issue resolution, and vendor queries.
• Update SOPs, working practices, and guidelines.
• Mentor and develop team members and onboarding activities.
• Coordinate with reporting managers for audits and client meetings.
• Contribute to process improvements in programming and documentation.

Skills

Project Management

Change Management

CRM (Customer Relationship Management)

Vendor Management

Microsoft Office

System Integration

Drug Safety Systems

Education

Life Science or IT/Computing degree

Tools

Argus

ARISg

Veeva

SQL

Job description

Job Overview:

• Assist with the overall Safety system implementation, support, configuration, and migration related activities.
• Responsible for providing 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 an appropriate quality of service in a safe and cost-effective manner.
• Provide supervision and day-to-day management of projects, ensuring quality, compliance, and timely delivery.
• 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:

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.

Experience (Minimum Required):

• 6+ years of experience in drug safety systems such as Argus/ARISg/Veeva, with a minimum of 2 years of project management experience.
• 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.

Preferred Qualifications Include:

• Clinical background working with clinical systems - Good to have.
• Good understanding of SQL programming language - Good to have.
• Experience working with ticket support applications.

Physical Demands / Work Environment:

Office/Home-Based:

• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.

Physical Requirements:

• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Light to moderate lifting and carrying, or moving of objects, including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.

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