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

0-2 years
Not Disclosed
10 Oct. 10, 2025
Job Description
Job Type: Full Time Remote 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
(ARGUS Console or Veeva Safety preferred)

Company: Syneos Health
Location: Remote – India (IND)
Job ID: 25101877
Updated: Yesterday


About Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions organization that partners with clients to accelerate success. We combine clinical development, medical affairs, and commercial expertise to deliver outcomes that meet modern healthcare challenges.

Our Clinical Development model puts both the customer and patient at the center of everything we do. With over 29,000 employees across 110 countries, we continuously innovate to simplify operations, enhance collaboration, and drive faster delivery of therapies that change lives.

Work Here Matters Everywhere.


Why Join Syneos Health

  • Comprehensive career development and progression opportunities

  • Supportive and engaging leadership

  • Technical and therapeutic training programs

  • Peer recognition and total rewards initiatives

  • Commitment to our “Total Self” culture, promoting authenticity and inclusion

  • A diverse and collaborative global community where everyone feels they belong


Position Summary

The Safety & PV Ops Specialist II – Technology Support plays a key role in managing and maintaining pharmacovigilance (PV) technology systems, including ARGUS Console or Veeva Safety.

This role ensures regulatory compliance, system accuracy, and data integrity while supporting PV operations and cross-functional project teams.


Key Responsibilities

General Responsibilities

  • Develop and maintain Job Aids, Standard Process Documents, and supporting documentation.

  • Ensure compliance with Standard Operating Procedures (SOPs), Policies, and SMPs.

  • Maintain up-to-date knowledge of FDA, EU, and ICH guidelines on safety and PV reporting.

  • Support annual revenue targets by ensuring accurate and timely recognition of BU activities.

  • Provide metrics and operational updates at regular intervals.

  • Perform other work-related duties as assigned.


Technology Responsibilities

  • Manage and maintain the Safety Database, including:

    • User setup and maintenance

    • Project-specific configurations

    • Routine patches and system updates

    • MedDRA and WHO Drug Dictionary updates

    • Performance Qualification (PQ) scripts for updates or changes

    • System maintenance for compliance with global reporting standards

  • Support management of other Safety & Pharmacovigilance (SPVG) tools (e.g., SharePoint).

  • Provide technical and project support related to safety database operations.

  • Assist in execution and validation of safety data migrations.

  • Generate queries, listings, and reports for internal, client, and regulatory purposes.

  • Participate in project meetings and contribute to system discussions.

  • Maintain expert knowledge of safety systems and PVG applications through meetings, training, and professional workshops.

  • Contribute to ongoing SPVG initiatives and process improvements.


Qualifications

Education

  • Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Computer Science, or related technical discipline.

  • Equivalent combinations of education and experience may also be considered.

Experience & Skills

  • Hands-on experience with Safety Database systems (ARGUS or Veeva Safety preferred).

  • Knowledge of medical terminology and pharmacovigilance principles.

  • Strong understanding of ICH guidelines and global safety regulations.

  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Visio, Outlook).

  • Excellent communication, presentation, and interpersonal skills.

  • Strong organizational, documentation, and time management abilities.

  • High attention to detail with ability to meet tight deadlines.

  • Capable of managing multiple priorities and making effective decisions.

  • Demonstrated ability to work independently and collaboratively.


About Syneos Health’s Global Impact

  • Partnered in 94% of all Novel FDA Drug Approvals (past 5 years)

  • Supported 95% of EMA Authorized Products

  • Delivered 200+ clinical studies across 73,000 sites and 675,000+ trial patients

We thrive on innovation, initiative, and challenging the status quo — working to improve patient lives worldwide.

🔗 Learn more: www.syneoshealth.com


Additional Information

  • Job responsibilities listed are not exhaustive and may be adjusted as needed.

  • Equivalent experience or education will be considered.

  • Syneos Health is committed to diversity, equality, and inclusion.

  • The company provides reasonable accommodations under the Americans with Disabilities Act (ADA) to support applicants and employees.


How to Apply

👉 Apply directly on the Syneos Health Careers Portal
or
💼 Join the Talent Network to receive updates about future job openings.


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