Job Title: Safety & PV Ops Specialist I
📅 Updated: August 22, 2025
📍 Location: India – Salem (Hybrid)
🆔 Job ID: 25000428
🏢 Department: Safety & Pharmacovigilance (SPVG)
🕒 Employment Type: Full-Time
✈️ Travel Requirement: Minimal (up to 15%)
🔍 About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization designed to accelerate customer success. With 29,000+ employees in 110 countries, we bring together clinical, medical, and commercial capabilities to develop innovative strategies that meet today’s market realities.
At Syneos Health:
We place customers and patients at the center of everything we do.
We thrive on innovation, agility, and collaboration.
Our culture embraces diversity, authenticity, and the Total Self philosophy — empowering every employee to bring their whole self to work.
🧭 Position Summary
As a Safety & PV Ops Specialist I, you will support operational activities across the Safety & Pharmacovigilance Business Unit (SPVG). Your contributions will span project delivery, training, system setup, document management, and process improvement initiatives. You will work closely with cross-functional teams including Project Managers, Safety Coordinators, and technical specialists.
✅ Key Responsibilities
1. General Operations
Maintain repositories for training, finance, proposal tracking, audit logs, and departmental metrics.
Develop and update Job Aids and process documents.
Stay current with FDA, EU, and ICH safety and PV regulations.
Support annual revenue targets by collaborating with SPVG and Therapeutic BU teams.
Deliver agreed-upon metrics and assist with other assigned duties.
2. Quality & Compliance
Assist in quality planning, document development, and controlled document management.
Track and communicate quality metrics.
Identify and mitigate risk areas through quality assurance support.
Coordinate with Corporate Quality Assurance (CQA) on open quality issues (QIs).
Support audit and inspection readiness.
3. Training & Development
Design, develop, and present training materials (planned/ad hoc).
Manage Learning Management System (LMS) oversight for SPVG.
Develop PV-specific modules for accreditation programs.
Liaise with leadership to determine appropriate content.
4. Technology & Safety Systems
Participate in system audits, demos, and validation/testing activities.
Administer and configure safety systems such as Argus per project needs.
Support development and maintenance of SOPs and Work Instructions.
Assist in system troubleshooting and end-user support.
Maintain compliance with GCP, ICH, SOPs, and applicable regulations.
Develop safety reporting tools and perform data quality checks.
Train and mentor junior safety application specialists.
Assist in safety system data migrations and generate custom reports.
5. Proposal Development & Business Support
Collaborate with operational teams to support gross profit (GP%) targets.
Attend strategic planning and proposal calls.
Draft accurate SPVG content for RFPs and RFIs.
Assist with budget scope changes and proposal updates.
Maintain and update costing models and proposal templates.
Support bid defense and project handover meetings as needed.
🎓 Qualifications & Experience
Education
Bachelor's degree in Life Sciences, Nursing, Pharmacy, Computer Science, or related technical field.
(Equivalent experience may be considered)
Experience & Skills
Knowledge of Safety Database Systems and moderate medical terminology required.
Preferred: Clinical research or CRO experience, including systems/data collection.
Strong understanding of FDA/EU/ICH safety & pharmacovigilance regulations.
High proficiency in:
Microsoft Office (Word, Excel, PowerPoint, Outlook, Visio)
Relational databases
Business reporting tools (e.g., Crystal Reports, Oracle Insight, SQL Plus)
Ability to:
Work independently and in teams
Prioritize multiple tasks and deadlines
Communicate effectively (written & verbal)
Pay close attention to detail
Make sound decisions under pressure
💼 Work Environment
Hybrid work model based in Salem, India.
Travel may be required up to 15%.
🌎 Why Join Syneos Health?
Career development and clear progression paths.
Supportive leadership and a culture of recognition.
Inclusive and diverse environment where every voice matters.
Work with:
94% of all FDA novel drug approvals
95% of EMA-authorized products
200+ studies across 73,000 sites and 675,000+ trial patients
📌 Additional Information
Responsibilities and duties may evolve based on business needs.
Equivalent education, skills, or experience may be considered.
Syneos Health is committed to equal opportunity, inclusivity, and compliance with the Americans with Disabilities Act and other relevant legislation.
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💬 Encouragement to Apply
Even if your experience doesn’t align 100%, we encourage you to apply. Transferable skills are valued, and Syneos Health is committed to building a workplace where you belong.
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