Safety & PV Ops Specialist I
Job ID: 25000428
Location: IND – Remote
Updated: August 22, 2025
Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating biopharma success. We deliver clinical, medical affairs, and commercial solutions to improve healthcare outcomes.
Fast facts:
29,000+ employees
Operating in 110 countries
Partnered in 94% of all novel FDA approvals in the past 5 years
Involved in 200+ studies at 73,000 sites, serving over 675,000 patients
🔗 Learn more: www.syneoshealth.com
Career growth: Strong focus on employee development and progression
Supportive environment: Engaged leadership, peer recognition, and total rewards
Inclusive culture: "Total Self" philosophy promotes authenticity, diversity, and well-being
Remote flexibility: Work-from-home opportunities for better work-life integration
As a Safety & PV Ops Specialist I, you will support multiple functions within the Safety & Pharmacovigilance (SPVG) Business Unit. Responsibilities include document control, training coordination, technology support, compliance tracking, database configuration, and proposal development.
Maintain repositories for training, finance, RFI library, proposal tracking, audit logs, etc.
Create/update job aids and process documents
Stay current on FDA/EU/ICH safety & PV regulations
Support SPVG revenue tracking and BU recognition in RBB
Provide SPVG metrics on a regular basis
Perform other assigned tasks as needed
Travel: Up to 15% (minimal)
Assist with controlled document creation and revision
Track and communicate quality metrics
Support quality control and assurance activities
Identify risks through process assessments
Liaise with QA and management to resolve Quality Issues (QIs)
Support audit and inspection readiness for safety projects
Develop and deliver training materials (e.g., Safety Specialist, Coordinator, revenue recognition)
Oversee training content and updates in the Learning Management System (LMS)
Create PV-specific modules for an accreditation program
Participate in audits and system demonstrations
Support implementation, validation, and documentation of Safety Systems
Maintain SOPs and WIs for technology processes
Configure and manage Argus Safety database per sponsor requirements
Maintain and troubleshoot Argus and other systems (e.g., ArisG, Clintrace)
Develop and validate reports and tools (e.g., Business Objects)
Create Argus-related forms (project info, licenses, access, report requests)
Train and mentor junior Safety Application Specialists
Support Safety System migrations, data transfers, and reporting
Represent the Safety Applications team in project/client meetings
Stay informed on global regulations, GCP, ICH, and drug/device development standards
Help meet SPVG gross profit targets by tracking financial metrics and cost models
Attend strategy and bid defense meetings
Support creation of accurate budgets, proposals, and response documents for RFPs/RFIs
Coordinate with SPVG leaders to define scope of work and named resources
Maintain and update proposal templates, cost models, and slide decks
Liaise with Contracts, Project Managers, and Safety teams for budget adjustments
Bachelor’s degree in life sciences, nursing, pharmacy, computer science, or related technical field
Equivalent experience may be considered
Working knowledge of Safety Database Systems and medical terminology
Experience in clinical research, data collection, or CRO/pharmaceutical environments preferred
Strong database and reporting tool experience preferred:
Oracle Insight/Analytics/Data Mart
Crystal Reports/Business Objects
SQL Plus
Deep understanding of ICH, GCP, and pharmacovigilance regulations
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Visio), Outlook, and internet tools
Excellent written and verbal communication and interpersonal skills
Strong documentation and organizational skills
Ability to prioritize and manage multiple projects simultaneously
Independent and team-oriented work style
Detail-oriented and deadline-driven
Effective decision-making and multi-tasking abilities
Travel: Up to 15% as needed
94% of all novel FDA-approved drugs supported
95% of EMA-authorized drugs
200+ studies with global reach
Tasks and responsibilities may evolve
Equivalent qualifications and experience are considered
Compliant with EU Equality Directive and ADA for accommodations
👥 Not ready yet? Join the Talent Network
We value authenticity and encourage candidates with transferable skills to apply—even if your experience doesn’t match the job description exactly. At Syneos Health, you belong.
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