Safety & PV Ops Specialist I
📍 Location: Gurugram, India
🆔 Job ID: 25000428
📅 Last Updated: August 22, 2025
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization. We drive clinical, medical, and commercial innovations to accelerate the development and delivery of therapies.
Key facts:
29,000 employees across 110 countries
Involved in 94% of novel FDA approvals over the past 5 years
Supported 200+ studies across 73,000 sites and 675,000+ patients
🔗 Learn more: www.syneoshealth.com
🚀 Career growth: Structured development plans and advancement opportunities
💼 Supportive environment: Inclusive leadership, peer recognition, and strong team culture
🌍 Total Self culture: Encouraging authenticity, diversity, and global belonging
🏠 Flexible location: Remote work options and minimal travel (up to 15%)
The Safety & PV Ops Specialist I provides operational support to the Safety & Pharmacovigilance (SPVG) Business Unit, assisting with training, documentation, system setup, compliance, and proposals. This role contributes to project delivery, system maintenance, and process improvement initiatives.
Maintain repositories for training materials, project finance documents, proposal tracking, audits, etc.
Develop and maintain process documents and job aids
Ensure compliance with FDA/EU/ICH safety and PV regulations
Collaborate with BU PMs and project directors to meet revenue recognition targets
Track and report SPVG metrics at defined intervals
Perform additional assigned duties
Support quality planning and document control
Track and communicate quality metrics
Support quality assurance, identifying risks and resolving QIs in liaison with CQA
Help teams maintain audit and inspection readiness
Develop and present training materials (Safety Specialist, Safety Coordinator, etc.)
Oversee Learning Management System (LMS) for SPVG training programs
Create PV-specific content for internal accreditation programs
Participate in audits and system demos
Assist in implementation, validation, and documentation of safety systems
Create and maintain SOPs/WIs for safety system operations
Configure and maintain Argus Safety database per project requirements
Troubleshoot Argus and alternate systems (e.g., ArisG, Clintrace)
Assist with data migrations, reporting, and quality checks
Develop Argus-related training materials and mentor junior staff
Maintain knowledge of global drug regulations and system compliance
Represent Safety Applications in client/project meetings
Support SPVG annual GP% targets through financial tracking
Participate in strategy calls and assist with safety proposal development
Prepare accurate budgets, SOWs, and RFP/RFI responses
Update SPVG proposal templates, cost models, and slide decks
Attend bid defense and project handover meetings
Liaise with contracts and project teams for scope/budget adjustments
Bachelor’s in Life Sciences, Nursing, Pharmacy, Computer Science, or related field
Equivalent experience may be considered
Required:
Familiarity with safety database systems and medical terminology
Knowledge of FDA/EU/ICH regulations in safety and pharmacovigilance
Proficiency in MS Office (Word, Excel, PowerPoint, Visio), Outlook, and web tools
Strong organization, documentation, and time management skills
Ability to work independently and in teams
Excellent communication and interpersonal skills
Detail-oriented with ability to meet deadlines and manage priorities
Preferred:
Experience in clinical research or CRO industry
Working knowledge of Oracle Insight, Data Mart, Crystal Reports, SQL Plus, Business Objects
Minimal travel required (up to 15%)
Syneos Health values diversity and encourages candidates with transferable skills to apply—even if their background doesn’t fully match the job description. Join a culture where everyone belongs.
🔗 Apply Now
🤝 Or Join Our Talent Network
Responsibilities may change at the company’s discretion
Equivalent education/experience combinations will be considered
This description is compliant with global labor and non-discrimination regulations (EU Equality Directive, ADA, etc.)
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