Job Title: Senior Safety & PV Operations Specialist
Company: Syneos Health
Location: Hyderabad, India (Hybrid)
Job ID: 25001808
Updated On: April 11, 2025
Employment Type: Full-time
Travel Requirement: Minimal (up to 15%)
Job Summary
Syneos Health is seeking a Senior Safety & Pharmacovigilance (PV) Operations Specialist to join its hybrid team in Hyderabad. The role focuses on supporting safety operations, quality and compliance, training, technology systems (notably Argus), and proposal development within the SPVG unit.
Key Responsibilities
General
Maintain repositories for training, finance, proposals, and metrics.
Track SPVG project performance and facilitate revenue target achievement.
Prepare and present SPVG metrics and reports.
Quality & Compliance
Develop and maintain controlled documents.
Support quality planning, compliance, and assurance efforts.
Aid audit and inspection readiness.
Training
Create and deliver training materials.
Oversee LMS activities and PV-specific training accreditation.
Technology
Manage Argus database configurations per project needs.
Provide support for safety systems, perform troubleshooting, and assist with data migrations.
Develop safety system reports and custom listings/queries.
Proposals
Contribute to the creation of proposals and budgeting for SPVG tasks.
Maintain template text, costing models, and support bid defense processes.
Required Qualifications
Bachelor's in Life Sciences, Nursing, Pharmacy, Computer Science, or related field.
Familiarity with safety database systems and medical terminology.
Strong knowledge of ICH guidelines and global safety regulations.
Proficiency in MS Office Suite; experience with SQL, Business Objects, or Oracle tools preferred.
Experience in clinical research, PV operations, or safety data systems preferred.
Key Skills
Excellent communication and interpersonal skills.
Ability to multitask, prioritize, and work independently or in teams.
Strong organizational and problem-solving skills.
Attention to detail with a focus on accuracy and compliance.
About Syneos Health
Syneos Health is a global, biopharmaceutical solutions organization with a workforce of over 29,000 employees across 110 countries. Their mission is to accelerate therapy delivery through integrated clinical, medical, and commercial solutions. With a culture rooted in authenticity and innovation, Syneos promotes career development and inclusivity at all levels.
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