Job ID: 25000428
Location: IND – Gurugram (Hybrid)
Updated: August 22, 2025
Syneos Health® is a fully integrated biopharmaceutical solutions company that combines clinical development, medical affairs, and commercial capabilities to bring therapies to market faster. With 29,000 employees in over 110 countries, we’re driven by the mission to change lives through innovation and collaboration.
“WORK HERE MATTERS EVERYWHERE”
🌍 Global exposure in a leading CRO environment
🚀 Career growth through technical training, mentorship, and leadership support
🌱 Commitment to diversity, inclusion, and authenticity through our Total Self Culture
🏆 Recognition through performance-based rewards
🤝 Work on cutting-edge projects supporting novel FDA and EMA drug approvals
The Safety & PV Ops Specialist I provides operational support to the Safety and Pharmacovigilance (PVG) Business Unit. You will assist delivery leads in managing systems setup, documentation, training, compliance, and other department-level tasks to support operational excellence.
Maintain repositories for training records, finance trackers, proposals, RFI libraries, metrics, and audits/inspections
Develop and update process documents and job aids
Stay informed on FDA/EU/ICH safety and PV regulations
Track SPVG metrics and financial data for accurate business recognition
Perform ad-hoc duties as assigned (limited travel up to 15%)
Support development, revision, and control of departmental documents and SOPs
Help perform quality checks and track quality metrics
Identify risk areas and communicate them for resolution
Support audit and inspection readiness across safety project teams
Develop and deliver training materials (planned or ad hoc)
Oversee Learning Management System (LMS) for Safety & PVG
Create PV-specific training modules for accreditation programs
Participate in system audits and demos
Support implementation and validation of Safety Systems
Configure and maintain Argus Safety database per sponsor requirements
Troubleshoot and train users on Argus, ArisG, Clintrace, and other safety systems
Generate and QC listings, reports, and queries from safety databases
Develop Argus-related training materials and mentor junior Safety Application Specialists
Plan and execute safety system data migrations and custom reports
Maintain expertise in safety and PVG systems through workshops and internal meetings
Contribute to proposal strategy and development for Safety & PVG components
Ensure accuracy in budgets, scope of work, and proposal responses (RFPs/RFIs)
Attend bid defense and project hand-over meetings as needed
Maintain and update SPVG proposal templates, costing models, and presentation slides
Analyze financial data to align with gross profit (GP%) targets
Bachelor’s degree in life sciences, nursing, pharmacy, computer science, or related field
Equivalent education and experience may be considered
Familiarity with safety database systems and medical terminology
Experience in clinical research, data collection, or safety operations preferred
Knowledge of ICH guidelines, GCP, and pharmacovigilance regulations
Strong computer skills, especially in:
Microsoft Office Suite (Word, Excel, PowerPoint, Visio)
Oracle Insight/Analytics, Data Mart, Crystal Reports/Business Objects, SQL Plus (preferred)
Excellent communication and interpersonal skills
Strong organizational and documentation abilities
Detail-oriented with high accuracy and decision-making skills
Ability to multitask, prioritize, and manage competing deadlines
Comfortable working independently and in a team
Willingness to travel (up to 15%)
Worked with 94% of all novel FDA-approved drugs in the last 5 years
Partnered in 95% of EMA-authorized products
Supported 200+ studies across 73,000 sites and 675,000+ trial patients
Explore more at: www.syneoshealth.com
Job responsibilities are not exhaustive and may change based on company needs
Equivalent qualifications will be considered
The role complies with global labor laws, including the EU Equality Directive and ADA (reasonable accommodations available)
This position supports operational activities in the Safety & Pharmacovigilance BU, including training, documentation, system setup, compliance, proposal development, and process improvement. You will assist safety delivery leads and work closely with internal stakeholders to drive compliance and operational efficiency.
👥 Not ready? Join our Talent Network
We’re committed to a workplace that fosters diversity, inclusion, and authenticity. If your experience doesn’t exactly match the job description, we still encourage you to apply. We value transferable skills and unique perspectives.
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