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Safety & Pv Ops Specialist I

2+ years
Not Disclosed
10 Aug. 29, 2025
Job Description
Job Type: Hybrid Education: Bachelor’s degree in life sciences, nursing, pharmacy, computer science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🧾 Job Title: Safety & PV Ops Specialist I

Job ID: 25000428
Location: IND – Gurugram (Hybrid)
Updated: August 22, 2025


🧬 About Syneos Health

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”


💼 Why Join Us?

  • 🌍 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


🎯 Role Summary

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.


🔍 Key Responsibilities

📁 General Support

  • 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%)


🧪 Quality & Compliance

  • 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


📚 Training

  • 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


🖥️ Technology & Systems

  • 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


📊 Proposals & Business Support

  • 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


✅ Required Qualifications

Education

  • Bachelor’s degree in life sciences, nursing, pharmacy, computer science, or related field

  • Equivalent education and experience may be considered

Experience & Technical Skills

  • 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)

Competencies

  • 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%)


🌍 About Syneos Health (Quick Facts)

  • 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


🔎 Additional Notes

  • 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)


📝 Summary

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.


📬 How to Apply


🌈 Diversity & Inclusion Commitment

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.