Safety & PV Ops Specialist I – Remote (India)
Location: India – Remote
Updated: August 22, 2025
Job ID: 25000428
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization that partners with customers to accelerate the delivery of life-changing therapies. With 29,000 employees across 110 countries, we bring together clinical development, medical affairs, and commercial expertise to help clients succeed in an evolving healthcare market.
Work Here Matters Everywhere.
Role Overview
The Safety & Pharmacovigilance (PV) Operations Specialist I provides operational and systems support across safety data management, compliance, training, and proposal activities. This remote position is ideal for candidates with strong safety database expertise (Argus, ArisG, Clintrace) and knowledge of global PV regulations. You’ll collaborate with global teams to maintain high-quality safety deliverables, support inspections, and improve departmental processes.
Key Responsibilities
General & Compliance
Maintain repositories of PV documents, training records, proposals, and audit tracking.
Ensure compliance with ICH, FDA, EMA, and GVP safety reporting requirements.
Provide SPVG metrics and support annual revenue and profitability goals.
Support audit and inspection readiness across projects.
Training
Develop and deliver PV-specific training materials for staff and system users.
Manage Learning Management System (LMS) activities.
Contribute PV-specific modules to accreditation programs.
Technology
Configure, validate, and maintain Argus Safety and other safety databases.
Troubleshoot database issues and support data migrations, listings, and reporting.
Generate safety reports, queries, and regulatory submissions.
Assist in development and validation of reporting tools (e.g., Business Objects).
Mentor junior specialists and contribute to SOP/WI development.
Proposals
Support RFP/RFI responses by providing budget, scope, and SPVG content.
Maintain costing model accuracy with real-time project budget updates.
Attend bid defense and project handover meetings as needed.
What We’re Looking For
Education: Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Computer Science, or related field.
Experience: Prior exposure to PV systems and safety databases (Argus, ArisG, Clintrace).
Technical Skills: MS Office (Word, Excel, PowerPoint, Visio), SQL Plus, Business Objects/Crystal Reports preferred.
Knowledge: Strong grasp of ICH guidelines, GCP, and PV regulations.
Strong organizational, documentation, and communication skills.
Ability to multitask, prioritize, and make effective decisions.
Minimal travel required (up to 15%).
Why Join Syneos Health
Remote flexibility with global collaboration.
Competitive compensation & performance-driven rewards.
Career growth through mentoring, technical training, and certifications.
Inclusive culture driven by our Total Self philosophy, ensuring authenticity and belonging.
Opportunity to work on 94% of FDA-approved novel drugs and 95% of EMA-authorized products over the past 5 years.
Expected Salary
The typical salary range for this role in India is ₹6–10 LPA, depending on experience and technical expertise.
Apply Now
Join Syneos Health as a Safety & PV Ops Specialist I (Remote, India) and play a key role in safeguarding patients while advancing global clinical research.
🔗 Learn more about Syneos Health
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