Safety & Pharmacovigilance Operations Specialist II – Technology Support (ARGUS Console / Veeva Safety)
Job Requisition ID: 25101877
Employment Type: Full-Time
Work Mode: Remote (Pre-approved)
Eligible Locations: India | Mexico | Brazil | Argentina | Chile
Experience Required: 4–7 Years
Function: Pharmacovigilance Operations | Safety Systems | PV Technology Support
About the Company
Syneos Health® is a globally recognized, fully integrated biopharmaceutical solutions organization supporting clinical development, medical affairs, and commercialization. Operating across 110+ countries with more than 29,000 professionals, Syneos Health partners with leading life sciences organizations to accelerate the delivery of innovative therapies worldwide.
Role Overview
Syneos Health is seeking a Safety & PV Operations Specialist II – Technology Support to provide functional and technical expertise in pharmacovigilance systems. This role focuses on the administration, configuration, maintenance, and optimization of global safety databases, with a strong preference for experience in Oracle Argus Console or Veeva Safety.
The ideal candidate will bring a blend of pharmacovigilance knowledge, regulatory compliance expertise, and safety system administration experience to support global safety operations in a remote, cross-functional environment.
Key Responsibilities
PV Systems & Technology Support
Support the configuration, administration, and ongoing maintenance of safety databases, including user access management and project-level setup
Perform routine system updates, patches, MedDRA and WHO Drug Dictionary upgrades
Execute and document Performance Qualification (PQ) testing for system changes and upgrades
Support safety data migrations, system validations, and compliance documentation
Generate safety listings, queries, and regulatory reports for internal, sponsor, and health authority use
Operational & Compliance Support
Ensure compliance with SOPs, Safety Management Plans (SMPs), company policies, and global regulatory requirements
Maintain up-to-date knowledge of FDA, EMA, ICH, and global pharmacovigilance regulations
Provide safety system support for ongoing Safety and PVG projects, including troubleshooting and data output support
Assist with the maintenance of related PV applications and platforms (e.g., SharePoint)
Documentation, Metrics & Collaboration
Develop, update, and maintain job aids, system guides, and process documentation
Provide operational metrics and system performance reports at agreed intervals
Participate in cross-functional project meetings and collaborate with operational and therapeutic teams
Support business unit revenue recognition activities by ensuring accurate system data and reporting
Education & Experience Requirements
Education:
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Computer Science, Information Technology, or a related field
Equivalent combinations of education and relevant experience will be considered
Experience:
4–7 years of experience in pharmacovigilance operations, safety systems, or PV technology support
Hands-on experience with Oracle Argus Console and/or Veeva Safety is strongly preferred
Prior experience supporting global safety databases in a regulated environment
Required Skills & Competencies
Strong understanding of pharmacovigilance processes and global safety regulations
Working knowledge of ICH guidelines related to safety reporting
Proficiency in safety database systems and moderate medical terminology
Advanced documentation, organizational, and validation skills
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Visio, Outlook)
Ability to manage multiple priorities independently in a remote environment
Strong communication, presentation, and stakeholder management skills
High attention to detail with the ability to meet strict timelines
Why Join Syneos Health
Opportunity to work remotely on global pharmacovigilance technology initiatives
Exposure to large-scale safety databases and global regulatory environments
Strong emphasis on professional development, training, and career progression
Inclusive, collaborative, and innovation-driven work culture
Equal Opportunity Statement
Syneos Health is an equal opportunity employer and is committed to providing a diverse and inclusive workplace in compliance with all applicable employment laws.
Apply now on thepharmadaily.com to advance your career in Safety & Pharmacovigilance Technology Operations with a globally trusted life sciences organization.
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Sheffield |Oxfordshire :
Witney |Ontario :
Richmond Hill | Mississauga | Uxbridge | Australia | North York | Renfrew |Canada :
Canada |Quebec :
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Brussels |Antwerp :
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Zaventem |South America :
Argentina | Peru |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Madrid |Cebu Province :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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