Senior Safety System Specialist

Fortrea; Bengaluru; Remote; INR 900,000 - 1,400,000; Full time

Job summary

Fortrea is seeking a Safety Systems Analyst to assist with the deployment, configuration, migration, and ongoing support of pharmacovigilance safety systems. You will collaborate with business stakeholders to gather requirements, develop reports, and ensure timely delivery in a cost-effective manner.

The role involves user training, SOP updates, data extraction, and participation in data migration activities while maintaining compliance with PV regulations.

Qualifications

• Life Science or IT/computing degree.
• 3+ years of experience with drug safety systems such as Argus/ARISg/Veeva.
• Good working knowledge of Microsoft Office tools.
• System integration knowledge.

Responsibilities

• Lead configuration of Safety systems and document changes.
• Develop and document standard and ad hoc reports from safety systems.
• Educate end users and sponsors on safety systems.
• Support data migration activities and related documentation.
• Perform data extraction (PSURs, DSURs, listings) as required.
• Respond to queries and maintain SOPs and guidelines.

Skills

MS Office

System integration

SQL programming

Education

Life Science or IT/computing degree

Tools

Argus/ARISg/Veeva

Job description

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. Expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company's Health and Safety Manual

Summary of Responsibilities:

• PV systems team member responsible for leveraging a strong combination of business and technical knowledge.
• Conduct project specific configurations in Safety systems.
• Maintain and document system configuration based on initial requirements and any subsequent changes.
• Develop and document standard and ad hoc reports from the safety systems.
• 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).
• Conduct routine and ad hoc data extraction (i.e. PSURs, DSURs, 6-monthly listings).
• Actively participate in all data migration activities and documentation related to migration.
• Support with change management and training of the systems, as needed.
• Expertise in Ticket management, issue resolution and escalating system issues where applicable.
• Making updates to Departmental Standard Operating Procedures, Working Practices and Guidelines.
• Subject matter expert, looking for ways to improve compliance, quality and efficiency.
• Respond to mailbox queries.
• Completing work assignments to the highest quality standards, adhering to relevant SOPs and keeping up to date with knowledge of current PV regulations.
• Perform User Acceptance Testing and complete required documentation.
• Collaborate with training team in development of safety system specific training module.
• Provide overall guidance and strategize use of standard safety systems front-end reporting including use of advanced conditions and Standard MedDRA Queries (SMQ).
• 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.
• Any other duties as assigned by management.
• 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.
• At least 3 years of experience with drug safety systems such as Argus/ARISg/Veeva or equivalent.
• Good working knowledge of Microsoft office tools.
• System integration knowledge.

Experience (Minimum Required):

• Experience in systems operations support role.
• Experience working on any validated document management.
• Good keyboard skills, preferably with knowledge of MS office and Windows.
• Ability to operate standard office equipment.

Preferred Qualifications Include:

• Life Science or IT/computing degree
• Clinical background working with clinical systems.
• Good understanding of SQL programming language.
• 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.

Physical Demands/Work Environment:

• Office Environment or remote.

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