Safety & Pharmacovigilance (PV) Operations Specialist I
India – Pune
25000428
August 22, 2025
Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We convert unique clinical, medical affairs, and commercial insights into outcomes addressing modern market challenges.
Our Clinical Development model centers on the customer and patient, continuously simplifying and streamlining processes for operational excellence. Join a global team of passionate problem solvers dedicated to delivering life-changing therapies.
Global Impact: 29,000 employees across 110 countries
Experience: Supported 94% of novel FDA-approved drugs and 95% of EMA-authorized products over the past 5 years.
As a Safety & PV Ops Specialist I, you will provide operational support across multiple areas within the Safety & Pharmacovigilance Business Unit (BU). You will assist project delivery leads with training management, document filing, system setup, and access requests. You will also contribute to department-level tasks, process improvements, and tool development.
Develop and maintain repositories for key documents (training materials, project finance, proposals, audits, metrics).
Maintain job aids, process documents, and supporting documentation.
Stay updated on FDA/EU/ICH guidelines related to safety and pharmacovigilance reporting.
Support SPVG Annual Revenue targets through collaboration with operational teams and project managers.
Provide SPVG metrics as required.
Perform additional duties as assigned.
Minimal travel (up to 15%).
Support quality planning by managing controlled documents and quality metrics.
Facilitate quality compliance and quality control activities.
Assist quality assurance by identifying risks and liaising with Corporate Quality Assurance (CQA).
Maintain audit and inspection readiness for safety projects.
Plan, develop, track, and present training materials for Safety and Pharmacovigilance BU.
Manage Learning Management System (LMS) oversight.
Develop PV-specific training for accreditation programs.
Participate in audits, system demos, and Safety Systems validation projects.
Develop and maintain SOPs and Work Instructions related to Safety Systems.
Analyze and support regulatory report needs from Safety Systems.
Configure, administer, and maintain Argus Safety database per project requirements.
Develop, validate, and maintain Safety reporting tools (e.g., Business Objects).
Create and manage Argus project documentation and user access.
Troubleshoot Safety system issues and provide user support.
Train and mentor junior Safety Application Specialists.
Assist with alternate sponsor databases (e.g., ArisG, Clintrace).
Maintain compliance with SOPs, regulations, and guidelines.
Support data migrations, custom report generation, and quality checks.
Represent Safety Applications team in meetings.
Support SPVG Annual Gross Profit targets by working with operational teams.
Contribute to Safety and PVG proposal strategy and development.
Ensure accuracy of budgets, scopes, and proposal content.
Assist with contract scope/budget changes.
Maintain proposal templates and costing models.
Participate in bid defense and project hand-over meetings.
| Criteria | Details |
|---|---|
| Education | Bachelor’s degree in life sciences, nursing, pharmacy, computer science, technology, or equivalent |
| Experience | Knowledge of Safety Database systems and medical terminology |
| Industry Experience | Clinical research, data collection, or CRO/pharmaceutical experience preferred |
| Technical Skills | Proficiency in relational databases, Oracle Insight/Analytics, Business Objects, SQL preferred |
| Regulatory Knowledge | Strong understanding of ICH guidelines and safety/pharmacovigilance regulations |
| Software Skills | Microsoft Office Suite, Outlook, internet |
| Other Skills | Strong organizational, communication, presentation, and documentation skills |
| Work Style | Ability to work independently and in teams, multitask, meet deadlines, make effective decisions |
| Travel | Minimal travel may be required |
Focus on career development with training and progression opportunities
Supportive leadership and peer recognition programs
Inclusive “Total Self” culture fostering authenticity and belonging
Work on impactful projects within a global and agile environment
Job responsibilities may change at the company’s discretion.
Equivalent experience, skills, and education may be considered.
The company complies with all applicable employment laws, including ADA and EU Equality Directive.
This description is not an employment contract.
Apply now: Syneos Health Careers
Not ready? Join our Talent Network to stay connected with future opportunities.
Syneos Health is committed to building a diverse, inclusive workplace and encourages candidates with transferable skills to apply.
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Japan | Saitama |Tokyo :
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