Job Title
Safety & PV Ops Specialist I
Job Details
Updated: August 22, 2025
Location: Remote – India (IND-Remote)
Job ID: 25000428
Department: Safety & Pharmacovigilance (SPVG)
Employment Type: Full-Time
Travel: Minimal (up to 15%)
About Syneos Health
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization. With over 29,000 employees across 110 countries, we aim to accelerate customer success and improve patient outcomes. Our culture promotes diversity, authenticity, and continuous development through our Total Self culture and employee-focused programs.
Position Summary
The Safety & PV Ops Specialist I provides operational support to the Safety & Pharmacovigilance (SPVG) Business Unit across multiple areas including training, documentation, technology systems, compliance, quality assurance, and proposals. This role assists Safety Project Delivery Leads and contributes to process improvements, system configuration, data tracking, and SPVG proposal development.
Key Responsibilities
1. General Operations
Maintain SPVG documentation repositories (training records, finance, proposals, metrics, audits, etc.)
Develop and update job aids, process documents, and training materials.
Support revenue recognition processes and provide regular SPVG metrics.
Assist with additional assigned work-related tasks.
2. Quality & Compliance
Support controlled document development and revision processes.
Track and report on quality metrics.
Assist in identifying and resolving areas of compliance risk.
Liaise with Corporate Quality Assurance (CQA) for quality investigations (QIs).
Ensure audit and inspection readiness.
3. Training
Design and deliver training materials for SPVG staff (Safety Specialists, Coordinators, etc.)
Manage training records in the Learning Management System (LMS).
Support development of PV-specific content for accreditation programs.
4. Technology & Systems
Support validation, testing, and maintenance of safety systems (e.g., Argus).
Configure and administer project-specific setups in safety databases.
Troubleshoot technical issues with Argus and other safety platforms.
Assist with data migrations, reporting tools, and custom safety reports.
Train and mentor junior Safety Applications Specialists.
Maintain compliance with IT and safety systems SOPs/WIs.
5. Proposal & Business Development
Support proposal strategy planning by working with SPVG leadership.
Draft proposal content, budget, and scope of work for RFPs/RFIs.
Update SPVG costing models and templates.
Liaise with Contracts team for budget and scope changes.
Attend bid defense and project handover meetings as needed.
Required Qualifications
Bachelor’s degree in life sciences, nursing, pharmacy, computer science, or a related field.
(Or equivalent combination of education and experience)
Experience with safety database systems and medical terminology.
Prior experience in clinical research, data management, or pharmacovigilance preferred.
Familiarity with FDA/EU/ICH guidelines and GCP requirements.
Technical Skills
Strong knowledge of relational databases, especially Argus Safety.
Preferred experience with:
Oracle Insight / Analytics / Data Mart
Crystal Reports / Business Objects
SQL Plus
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Visio).
Soft Skills
Strong communication and presentation skills.
Excellent organizational and documentation abilities.
Able to prioritize multiple tasks and meet deadlines.
Comfortable working independently or as part of a team.
Decision-making and problem-solving capabilities.
Why Join Syneos Health?
Career development and progression programs.
Total rewards and peer recognition.
Supportive line management and leadership.
Inclusive culture where authenticity is valued.
Work with 94% of FDA novel drug approvals and 95% of EMA-authorized products.
Additional Information
This description may evolve based on business needs.
Equivalent experience or education may be considered.
The company complies with the Americans with Disabilities Act and provides reasonable accommodations as needed.
How to Apply
👉 Apply for this job
📌 Or join our Talent Network to stay informed on future opportunities.
Equal Opportunity Statement
Syneos Health is committed to fostering a diverse and inclusive workplace. If your experience doesn’t align perfectly with the job requirements, we still encourage you to apply.
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