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Safety & Pv Ops Specialist Ii - Technology Support (Argus Console Or Veeva Safety Preferred)

0-2 years
Not Disclosed
10 Oct. 19, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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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