Job Title:
Safety & PV Ops Specialist II – Technology Support
(ARGUS Console or Veeva Safety preferred)
Company: Syneos Health
Location: Remote – Brazil (BRA)
Job ID: 25101877
Updated: Yesterday
About Syneos Health
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization committed to accelerating customer success. We combine clinical, medical affairs, and commercial expertise to deliver results aligned with the realities of today’s healthcare market.
Our Clinical Development model centers around the customer and the patient, with a continuous focus on innovation, simplification, and collaboration.
With over 29,000 employees across 110 countries, we are passionate problem solvers, united by a mission to bring life-changing therapies to patients faster.
Work Here Matters Everywhere.
Why Join Syneos Health
Career development and professional growth opportunities
Supportive and engaged leadership
Technical and therapeutic training programs
Recognition and rewards initiatives
Commitment to the “Total Self” culture — empowering employees to be authentic
Inclusive and diverse work environment where everyone belongs
Position Summary
The Safety & PV Ops Specialist II – Technology Support will manage and support pharmacovigilance (PV) systems such as ARGUS Console or Veeva Safety, ensuring database integrity, compliance with global regulatory requirements, and efficient safety data operations.
This role involves collaboration with cross-functional teams to maintain, configure, and validate safety systems, generate reports, and support operational excellence.
Key Responsibilities
General Responsibilities
Develop and maintain Job Aids, process documents, and supporting materials.
Ensure full compliance with SOPs, Policies, and SMP documents.
Maintain updated knowledge of FDA, EU, and ICH safety/PV regulations.
Support annual revenue goals through coordination with operational teams and Project Managers.
Provide metrics and reports at agreed intervals.
Perform additional tasks as assigned to support departmental objectives.
Technology Responsibilities
Assist in managing and maintaining the Safety Database, including:
User setup and access maintenance
Project-specific configurations
Routine database patches and updates
Regular MedDRA and WHO Drug Dictionary updates
Execution and validation of Performance Qualification (PQ) scripts
Ensuring system compliance with safety reporting regulations
Support the management of SPVG applications (e.g., SharePoint).
Provide project-level support for database issues and data outputs.
Execute and validate safety data migrations.
Generate queries, reports, and listings for internal, client, and regulatory use.
Participate in project meetings and cross-functional discussions.
Maintain a high level of system expertise through training, internal meetings, and professional development.
Contribute to additional Safety & PVG initiatives as needed.
Qualifications
Education
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Computer Science, or a related technical field
Equivalent education and experience may be considered
Experience & Skills
Experience with Safety Database systems (preferably ARGUS Console or Veeva Safety)
Familiarity with medical terminology
Excellent knowledge of ICH safety and PV regulations
Strong proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Visio, Outlook)
Exceptional organizational, documentation, and communication skills
Ability to work both independently and collaboratively
Capable of managing multiple priorities and meeting tight deadlines
Attention to detail with a high degree of accuracy
Strong decision-making and problem-solving abilities
About Syneos Health’s Impact
Over the last 5 years, Syneos Health has:
Partnered in 94% of FDA Novel Drug Approvals
Supported 95% of EMA Authorized Products
Delivered 200+ studies across 73,000 sites and 675,000+ trial patients
We continuously challenge the status quo in a fast-evolving environment — driven by purpose and patient impact.
Learn more: www.syneoshealth.com
Additional Information
This job description outlines key duties but is not exhaustive.
The company reserves the right to assign additional tasks or adjust responsibilities as needed.
Equivalent experience or education may be considered in place of formal qualifications.
Syneos Health complies with the Americans with Disabilities Act (ADA) and provides reasonable accommodations when appropriate.
We are committed to equal employment opportunities and diversity in hiring.
How to Apply
👉 Apply directly on the Syneos Health Careers Portal
or
💼 Join the Talent Network to stay informed about new opportunities.
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