Safety & PV Ops Specialist I – Salem (Hybrid)
Location: Salem, India – Hybrid
Updated: August 22, 2025
Job ID: 25000428
About Syneos Health
Syneos Health® is a global, fully integrated biopharmaceutical solutions company helping accelerate customer success. With 29,000 employees across 110 countries, we work at the intersection of clinical development, medical affairs, and commercial solutions to bring therapies to patients faster.
Work Here Matters Everywhere.
Role Overview
As a Safety & Pharmacovigilance (PV) Operations Specialist I, you will provide operational support across safety systems, compliance, training, and proposals. This position requires expertise in Argus Safety and other PV systems, as well as knowledge of global regulatory requirements. You’ll collaborate with cross-functional teams to maintain quality, support audits/inspections, and deliver safety data that ensures patient well-being.
Key Responsibilities
General & Compliance
Maintain repositories of PV documentation, training records, proposals, and audit logs.
Ensure compliance with FDA, EMA, ICH, and GVP regulations.
Support audit and inspection readiness.
Provide SPVG metrics and contribute to annual revenue and gross profit targets.
Training
Develop and deliver PV training materials for staff and system users.
Manage Learning Management System (LMS) activities.
Create PV-specific training for accreditation programs.
Technology
Configure, validate, and administer Argus Safety database and other PV systems.
Troubleshoot safety database issues and support data migrations.
Generate regulatory and client safety reports, listings, and queries.
Mentor junior specialists and contribute to SOP/WI development.
Proposals
Support proposal strategy, RFP/RFI responses, and cost model updates.
Prepare budget and scope inputs for SPVG projects.
Attend bid defense and project handover meetings when needed.
What We’re Looking For
Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Computer Science, or related field.
Experience with safety databases (Argus, ArisG, Clintrace) and medical terminology.
Knowledge of ICH/GVP, FDA, EMA regulations.
Strong computer skills (MS Office; SQL Plus, Business Objects, Crystal Reports preferred).
Experience in clinical research or CRO environment preferred.
Excellent communication, documentation, and organizational skills.
Ability to multitask, prioritize, and make effective decisions.
Minimal travel required (up to 15%).
Why Join Syneos Health
Competitive compensation with performance-based rewards.
Hybrid working model for flexibility.
Career development, training, and mentoring opportunities.
Inclusive culture fostering authenticity and innovation.
Exposure to global safety operations and advanced PV systems.
Expected Salary
The typical salary range for Safety & PV Ops Specialists in India is ₹6–10 LPA, depending on experience and technical expertise.
Apply Now
Join Syneos Health in Salem as a Safety & PV Ops Specialist I and help drive patient safety while contributing to the success of global clinical trials.
🔗 Learn more about Syneos Health
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