Safety & PV Ops Specialist I
📍 Location: IND – Pune (Hybrid)
🆔 Job ID: 25000428
📅 Last Updated: August 22, 2025
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization accelerating customer success by combining clinical development, medical affairs, and commercial capabilities.
Fast facts:
29,000+ employees across 110 countries
Involved in 94% of FDA-approved novel drugs in the last 5 years
Partnered in 200+ studies across 73,000 sites and 675,000+ patients
🔗 Learn more: www.syneoshealth.com
🚀 Career development with structured training and progression
🤝 Supportive, diverse, and inclusive work environment
🧠 Technical and therapeutic area training programs
🌍 Total Self Culture: Encourages authenticity and belonging
🎉 Peer recognition and rewards programs
🏠 Hybrid work flexibility with minimal travel (up to 15%)
The Safety & PV Ops Specialist I supports operational activities within the Safety & Pharmacovigilance Business Unit (BU), assisting with training, system access, document management, process improvements, and proposal development. This role helps ensure regulatory compliance, data integrity, and team efficiency.
Maintain document repositories (training records, finance, proposal tracking, audit logs)
Create/update job aids, SOPs, and process documents
Keep updated on FDA/EU/ICH safety and PV guidelines
Support revenue recognition in coordination with BU PMs and project leads
Provide scheduled SPVG metrics
Perform other related tasks as needed
Support quality planning (controlled documentation, metrics, compliance verification)
Perform quality control and facilitate risk-based process assessments
Liaise with Corporate Quality Assurance (CQA) to resolve quality issues (QIs)
Help safety project teams prepare for audits/inspections
Develop, deliver, and track training materials (e.g., for Safety Specialists, Coordinators)
Oversee Learning Management System (LMS) for SPVG
Design pharmacovigilance-specific training for internal accreditation programs
Participate in audits, demos, and system validations
Support development and maintenance of SOPs/WIs for safety systems
Ensure compliance with IT SOPs related to Safety Systems
Generate regulatory and customer reports from safety systems
Administer and configure the Argus Safety Database per project
Maintain Argus project/product/user data and report request forms
Troubleshoot safety systems (Argus, ArisG, Clintrace, etc.)
Train and mentor junior Safety Application Specialists
Support safety data migrations and custom report creation
Participate in internal meetings and external client discussions on safety systems
Assist in achieving SPVG Gross Profit % targets
Attend strategy calls to shape SPVG proposal content
Collaborate with corporate and SPVG stakeholders on RFPs/RFIs
Develop and maintain proposal templates, slide decks, and cost models
Support budget/scope changes with Contracts team and BU PMs
Attend bid defense and project handover meetings as needed
Bachelor’s in Life Sciences, Nursing, Pharmacy, Computer Science, or related technical field
Equivalent combinations of education and experience may be considered
Familiarity with safety database systems and medical terminology
Knowledge of ICH and global PV/safety regulations
Proficiency in Microsoft Office (Word, Excel, PowerPoint, Visio, Outlook)
Strong organizational, documentation, and communication skills
Ability to prioritize and manage multiple tasks
Experience with relational databases and safety systems (e.g., Argus, ArisG, Clintrace)
Exposure to SQL, Oracle Analytics, Business Objects, Data Mart, Crystal Reports
Prior experience in clinical research or pharmaceutical/CRO industry
Minimal travel required (up to 15%)
Syneos Health is committed to building a diverse and inclusive workplace. Even if your experience doesn’t fully match, you’re encouraged to apply. Transferable skills are considered. You can also join our Talent Network to stay connected with future opportunities.
🔗 Apply Now on Syneos Health Careers
🧲 Or Join Our Talent Network
Responsibilities and tasks are not exhaustive and may be reassigned.
The company adheres to applicable global employment laws including the EU Equality Directive and the Americans with Disabilities Act.
Equivalent experience, education, or skills may be considered at the company’s discretion.
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
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Prague |Chile :
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