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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