Job Title: Safety & PV Ops Specialist II – Technology Support
Preferred Systems: ARGUS Console or Veeva Vault Safety
Updated: October 9, 2025
Location: IND – Remote
Job ID: 25101877
Company Overview
Syneos Health® is a fully integrated biopharmaceutical solutions organization designed to accelerate customer success.
With over 29,000 employees across 110 countries, we bring together clinical development, medical affairs, and commercial expertise to improve lives globally.
Motto: WORK HERE MATTERS EVERYWHERE
Why Join Syneos Health
Career development, progression, and mentoring opportunities.
Technical and therapeutic area training.
Recognition and total rewards programs.
Inclusive “Total Self” culture—where authenticity and belonging thrive.
Diverse, collaborative, and innovative global environment.
Job Summary
The Safety & PV Ops Specialist II – Technology Support plays a key role in managing and maintaining safety database systems (e.g., ARGUS or Veeva Vault Safety) and ensuring compliance with pharmacovigilance (PV) regulatory requirements.
The position involves technology and process support for PV operations, data migrations, documentation, and system validation.
Key Responsibilities
General Responsibilities
Develop and maintain Job Aids and process documents with complete supporting documentation.
Ensure compliance with SOPs, Policies, and Standard Management Procedures (SMPs).
Maintain current knowledge of FDA/EU/ICH guidelines and safety reporting regulations.
Support annual revenue targets by collaborating with Therapeutic BU Project Managers/Directors for accurate revenue recognition.
Provide metrics and reports at agreed intervals.
Perform additional work-related duties as assigned.
Technology Responsibilities
Assist in management and maintenance of the Safety Database, including:
User setup and maintenance.
Project-specific configuration.
Routine updates, patches, and validation testing.
MedDRA and WHO drug dictionary updates.
Performance Qualification (PQ) scripting and validation.
Support and maintain other PV applications (e.g., SharePoint).
Provide project-level technical support for Safety & PvG projects using the safety database.
Execute and validate safety data migrations into the system.
Generate listings, reports, and queries for internal, client, or regulatory use.
Participate in project meetings and ensure alignment with database requirements.
Maintain expertise in Safety & PvG systems through internal and external training sessions.
Support additional SPVG initiatives and technology improvements.
Qualifications
Education:
Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Computer Science, or a related technical field.
(Equivalent combinations of education and experience will be considered.)
Experience & Skills:
Knowledge of Safety Database systems (ARGUS, Veeva Vault, or similar).
Understanding of medical terminology and pharmacovigilance principles.
Excellent command of ICH guidelines and PV regulations.
Proficiency in Microsoft Office Suite (Word, Excel, Visio, PowerPoint), Outlook, and internet tools.
Strong organizational, documentation, and time management skills.
Detail-oriented with the ability to prioritize multiple tasks and meet deadlines.
Strong communication, presentation, and interpersonal skills (verbal and written).
Ability to make effective decisions and work independently or within a team.
Key Competencies
PV Systems Administration (ARGUS / Veeva)
MedDRA & WHO Drug Dictionary Management
Process Documentation & Compliance
Data Migration & Validation
Regulatory Reporting & Audit Readiness
Cross-functional Collaboration
About Syneos Health
Partnered with 94% of all novel FDA-approved drugs in the past 5 years.
Worked on 95% of EMA-authorized products and 200+ studies across 73,000 sites and 675,000+ patients.
Known for agility, innovation, and driving therapy delivery worldwide.
Website: www.syneoshealth.com
Additional Information
The responsibilities listed are not exhaustive and may evolve as required.
Equivalent experience, education, and skills may be considered in place of stated qualifications.
The company ensures compliance with global employment and disability legislation, including the Americans with Disabilities Act and EU Equality Directive.
Summary
Role: Safety & PV Ops Specialist II – Technology Support
Focus Areas: ARGUS / Veeva Safety, PV database maintenance, regulatory compliance, and process documentation.
Core Objective: Ensure efficient technology operations for pharmacovigilance systems supporting global safety and compliance initiatives.
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Bangor | Brewer |New Jersey :
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Tallinn |Hà Nội :
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Kyiv |Lima Region :
Lima |France :
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Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
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Sofia |Sweden :
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