Fortrea
Senior Safety System Specialist
India · Work style not stated · Full time
Apply on the employer’s site ↗See how well you match this job
You apply directly with the employer. ROLIVA does not submit applications from this page and is not the employer.
About the role
Description from the employer’s posting. Check the employer’s page for the current version.
- EmployerFortrea
- LocationIndia
- Work styleWork style not stated
- Employment typeFull time
- Employer posted
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.
Show full description
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.
Learn more about our EEO & Accommodations request here.
Check your resume against this job Free, no sign-up. Nothing you paste is stored.
Staying safe while you apply
- Never pay to apply, interview or accept an offer. ROLIVA never asks you for payment to apply to a job.
- Apply only through the official “Apply on the employer’s site” button, on the employer’s own site, and check that a recruiter’s email uses that employer’s own domain rather than a free email address.
- Be cautious of an offer made with no real interview, or pressure to decide quickly or share financial details early.
Does something look wrong with this listing? Use “Report broken link” in the role details, or read ROLIVA’s full job-safety guidance ↗.
Preparing for this role with ROLIVA
- Check the fit.
Compare the requirements with the experience you have confirmed, including gaps.
- Prepare honestly.
Build interview stories and application drafts from your own evidence.
- Keep track.
Save the role and record your own application status and follow-ups.
At a glance
- Employment typeFull time
- SenioritySenior
- Employer posted
- Added to ROLIVA
- Last checked
Skills in this posting
Skills ROLIVA found in the employer’s own description above. A mention is not a requirement.