Safety & PV Ops Specialist I
Salem, India – Hybrid
25000428
Updated On: August 22, 2025
Syneos Health® is a leading, fully integrated biopharmaceutical solutions company that partners with life sciences clients to accelerate success. We offer clinical, medical affairs, and commercial solutions to improve performance and deliver better outcomes for patients.
With 29,000+ employees across 110 countries, we are focused on streamlining processes and delivering faster, more impactful therapies.
🌐 Learn more: syneoshealth.com
🌱 Career growth and technical training
👥 Inclusive, supportive, and collaborative culture
🌎 Diversity of thought and global impact
🎯 Focused on simplifying work and maximizing results
🧠 Total Self culture – authenticity encouraged
🏆 Peer recognition and comprehensive rewards
WORK HERE MATTERS EVERYWHERE.
The Safety & PV Ops Specialist I provides operational support across multiple areas within the Safety & Pharmacovigilance (PVG) Business Unit. Responsibilities span documentation, training, systems setup, compliance, technology, and proposal development to ensure process excellence and regulatory alignment.
Maintain repositories for documentation (training, proposals, finance, audits, etc.)
Develop job aids, workflows, and process documentation
Stay up to date with FDA/EU/ICH PV reporting regulations
Support SPVG revenue tracking in RBB and ensure timely financial recognition
Provide SPVG metrics regularly
Perform other duties as assigned
Travel Requirement: Up to 15%
Support quality planning and controlled document processes
Assist in creating and updating department- or client-specific SOPs/WIs
Track and report quality metrics and risks
Collaborate with Corporate QA to resolve quality issues (QIs)
Ensure audit/inspection readiness of safety teams
Develop and deliver both scheduled and ad hoc training sessions
Collaborate with PV leadership to design training content (e.g., coordinator and specialist onboarding)
Manage LMS content and progress tracking
Create PV-specific content for internal accreditation
Assist with audits, demos, and system validations
Configure and maintain Argus Safety Database per sponsor requirements
Create and maintain project-specific forms and user access controls
Troubleshoot database and system issues (Argus, ArisG, Clintrace, etc.)
Develop and test safety reporting tools (e.g., Business Objects)
Support migration and custom report creation
Mentor junior Safety Application Specialists
Maintain SOP compliance and data integrity across all safety systems
Generate and QC listings, reports, and queries from safety databases
Participate in client meetings, demos, and internal technical discussions
Stay current with technical tools via seminars and team meetings
Support gross profit (GP%) planning and monitoring with project teams
Attend proposal planning calls and define Safety/PVG proposal strategy
Develop proposal responses to RFPs and RFIs (budget, scope, text)
Coordinate with Contracts, PMs, and SPVG leads on scope/budget changes
Update and maintain costing model templates and proposal slides
Attend bid defense and project hand-over meetings as needed
Bachelor's degree in Life Sciences, Pharmacy, Nursing, Computer Science, or a related field
Equivalent combinations of education and experience will be considered
Familiarity with safety databases and medical terminology
Clinical research, data collection, or pharma/CRO background preferred
Proficient in:
Microsoft Office Suite (Word, Excel, Visio, PowerPoint)
Email (Outlook), Internet
SQL Plus, Oracle Insight, Business Objects, Crystal Reports
Strong understanding of:
ICH, GCP, and global PV regulations
SOPs, WIs, and system compliance
Excellent written and spoken communication skills
Organized, detail-oriented, and deadline-focused
Effective decision-maker, able to manage competing priorities
Over the past 5 years, Syneos Health has:
Partnered on 94% of FDA-approved novel drugs
Worked on 95% of EMA-authorized products
Delivered 200+ clinical studies across 73,000+ sites with 675,000+ patients
Tasks and responsibilities may change based on company needs
Equivalent qualifications and transferable skills are encouraged
This description is not an employment contract
Syneos Health supports equal opportunities and provides accommodations under ADA and EU Equality Directives
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🚨 Even if your experience doesn’t align 100%, apply anyway — we value diverse and transferable skillsets.
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