Safety and PV Ops Specialist II
Company: Syneos Health
Location: India (Remote)
Job ID: 25106886
Experience: 3+ years in Pharmacovigilance (PV)
Role Overview
The Safety and PV Ops Specialist II supports the Safety & Pharmacovigilance (SPVG) Business Unit by contributing to operational support, quality systems, safety database management, training, and proposal activities. The role ensures compliance with regulatory standards and supports efficient PV operations across studies and clients.
Key Responsibilities
1. General & Operational Support
Maintain document repositories (training materials, finance data, audit/inspection lists, RFI libraries, metrics, etc.)
Develop and maintain job aids and process documentation
Ensure compliance with SOPs, policies, and safety/pharmacovigilance (PV) standards
Support revenue recognition activities and financial reporting coordination
Provide metrics and status updates as required
Support executive reporting and monthly finance meetings
Perform additional assigned operational tasks
Occasional travel (up to 10%)
2. Quality & Compliance
Support controlled document development, review, and updates
Track and report quality metrics for performance evaluation
Identify risks and support risk assessments
Participate in CAPA (Corrective and Preventive Action) processes
Support audit and inspection readiness activities
Assist in resolving quality issues with QA teams
Monitor compliance with SOPs and regulatory requirements
3. Training Support
Develop and maintain training materials for PV teams
Coordinate with senior stakeholders for training content updates
Manage Learning Management System (LMS) activities
Deliver training tracking, updates, and documentation
4. Technology & Systems Support
Assist with safety database administration:
User setup and maintenance
Project configuration
System updates and patches
MedDRA and WHO dictionary updates
Validation scripts and compliance checks
Support safety database migrations and data validation
Generate reports, listings, and queries for regulatory or client use
Support SharePoint and other SPVG systems
Participate in system-related project meetings
Ensure compliance with regulatory and company IT standards
5. Proposals & Business Support
Support proposal development and RFI responses
Assist in budget and cost model validation
Contribute to gross profit and financial planning support
Maintain proposal templates and standard content
Support change order tracking and updates
Collaborate with leadership for proposal strategy
Required Qualifications
Experience
Minimum 3+ years in Pharmacovigilance (PV)
Skills
Strong technical writing skills (PV domain preferred)
Good understanding of PV operations and regulatory expectations
Experience with:
Microsoft Office (Word, Excel, PowerPoint, PDFs)
Documentation and reporting tools
Strong written and verbal communication skills
Preferred Attributes
Experience in safety database systems or PV tools
Exposure to quality/compliance or training activities
Ability to work across multiple operational areas
Detail-oriented and process-driven mindset
About the Company
Syneos Health is a global life sciences organization supporting clinical development and pharmacovigilance across drug development programs worldwide. The company focuses on accelerating clinical research and improving patient outcomes through integrated services and global collaboration.
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