Safety & PV Ops Specialist I
Pune, India – Hybrid
25000428
Last Updated: August 22, 2025
Syneos Health® is a fully integrated biopharmaceutical solutions organization committed to accelerating customer success. Our global team transforms clinical, medical affairs, and commercial insights into actionable outcomes that impact patient lives.
With 29,000 employees across 110 countries, we offer a collaborative, fast-paced environment focused on innovative problem-solving and streamlined delivery of therapies.
🌐 Learn more: syneoshealth.com
Career Growth & Development: Clear pathways and ongoing training
Supportive Culture: Inclusive, collaborative, and authentic work environment
Recognition & Rewards: Total rewards program & peer recognition
Diversity & Inclusion: We celebrate diverse thoughts, backgrounds & cultures
Total Self Culture: Be your true self at work
WORK HERE MATTERS EVERYWHERE.
As a Safety & PV Ops Specialist I, you will support various operational functions across the Safety & Pharmacovigilance (PVG) Business Unit. This includes project documentation, system configuration, training coordination, quality assurance, and proposal development, helping ensure operational excellence and regulatory compliance.
Maintain centralized repositories for training materials, financials, proposals, RFIs, audit lists, and metrics
Create and update process documents, job aids, and supporting documentation
Stay current on FDA/EU/ICH PV reporting regulations
Support SPVG revenue targets and accurate recognition in RBB
Provide operational metrics at scheduled intervals
Perform other assigned tasks as needed
Travel: Up to 15%
Support document control processes for quality planning and audits
Develop and communicate quality metrics
Perform risk-based assessments and report potential issues
Liaise with internal QA and Corporate QA on open Quality Issues (QIs)
Ensure audit/inspection readiness of safety project teams
Design and deliver planned or ad hoc training programs for the PV BU
Work with leadership to develop content for specialist and coordinator roles
Manage LMS content and track completions
Create PV-specific training for internal accreditation
Participate in audits and provide system demos
Support system validation, testing, and documentation (e.g., Argus Safety)
Maintain SOPs/WIs related to safety systems
Configure and manage project-level Argus Safety database components
Troubleshoot issues in Argus, ArisG, Clintrace, and sponsor systems
Support development of reporting tools (e.g., Business Objects, SQL)
Create and maintain user access and reporting forms
Plan and execute system migrations and custom reports
Train and mentor junior Safety Application Specialists
Maintain system knowledge through meetings, workshops, and professional development
Collaborate on gross profit (GP%) targets with SPVG and project teams
Participate in strategy calls and develop proposal responses (RFPs/RFIs)
Ensure accuracy of budgets, scope, and proposal texts
Liaise with contracts and PMs on changes in scope or budget
Maintain and update costing models, templates, and SPVG proposal slides
Attend bid defense and handover meetings when required
Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Computer Science, or a related field
Equivalent education/experience combinations may be considered
Experience with safety databases and medical terminology
Clinical research, CRO, or pharmaceutical industry background preferred
Proficiency in:
Microsoft Office Suite (Excel, Word, PowerPoint, Visio)
Relational databases (Oracle Insight, SQL Plus, Crystal Reports/Business Objects)
Strong understanding of:
ICH/GCP/Drug Safety regulations
Data entry, analysis, and quality assurance processes
Strong communication and presentation skills
Ability to work independently and collaboratively
Exceptional time management and prioritization
High attention to detail and documentation accuracy
Proactive problem-solving and decision-making abilities
Deadline-oriented with multitasking capability
Over the past 5 years, Syneos Health has:
Worked on 94% of FDA-approved novel drugs
Supported 95% of EMA-authorized products
Managed 200+ studies across 73,000+ sites and 675,000+ patients
Tasks and responsibilities may change at the company’s discretion
Equivalent qualifications and transferable skills will be considered
This job description does not imply a binding employment contract
Syneos Health complies with all disability and equal opportunity laws
Reasonable accommodations provided upon request
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📌 Even if your experience doesn’t align 100%, we encourage you to apply. We value transferable skills and diverse experiences.
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