Syneos Health · 3 months ago
Safety & PV Ops Specialist II - Technology Support (ARGUS Console or Veeva Safety preferred)
United States
Full-time
Remote
Mid LevelSyneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. The Safety & PV Ops Specialist II will be responsible for developing and maintaining process documents, ensuring compliance with regulations, and managing safety databases to support pharmacovigilance efforts.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Develops and maintains Job Aids and process documents and maintains supporting documentation for these documents as needed
Ensures compliance to Standard Operating Procedures (SOP), Policies and SMP documents
Maintains knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and PV reporting
Supports annual revenue targets by working with the operational team members and Therapeutic BU Project Managers / Project Directors to ensure accurate and timely recognition of the BU in RBB
Provides metrics as appropriate at agreed upon intervals based on assigned tasks
Performs other work-related duties as assigned
Assist with the management and maintenance of the safety database, including but not limited to: User set-up and maintenance, Project-specific configurations, Routine safety database patches and updates, Routine MedDRA and WHO drug dictionary updates, Performance qualification (PQ) scripts for safety database updates/changes, Maintenance of systems to ensure compliance with reporting requirements
Assist with the management and maintenance of other SPVG applications (e.g. SharePoint)
Provide project support related to safety database issues and data outputs for Safety & PvG projects utilising the Syneos Health safety database
Assist with the execution and validation of safety data migrations into the safety database
Generate listings, reports and queries from the safety database for internal, client, or regulatory use
Participate in project meetings as requested
Ensure compliance with applicable regulatory requirements, company policies, procedures, and standards
Maintain a high level of expertise regarding Safety & PvG systems and applications through participation in internal meetings and professional seminars and workshops
Assist with other SPVG initiatives as needed
Qualification
Required
Bachelor's degree in life science, registered nurse, pharmacist, computer science or other technology related field (technical role), or equivalent combination of education and experience
Safety Database systems and moderate medical terminology required
Excellent knowledge of ICH guidelines and regulations relating to safety and pharmacovigilance
Proficiency in Microsoft Office Suite (Word, Excel, Visio, and PowerPoint), email (Outlook), and internet
Ability to work independently and in a team environment
Ability to successfully prioritize and work on multiple tasks
Excellent communication, presentation, interpersonal skills, both written and spoken
Strong organizational and documentation skills
Detail oriented with a high degree of accuracy and ability to meet deadlines
Able to make effective decisions
Manage multiple priorities
Preferred
ARGUS Console or Veeva Safety preferred
Benefits
Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Total Self culture
Company
Syneos Health
Syneos Health, the only fully integrated end-to-end clinical and commercial solution organization.
Founded in 1985
10001+ employees
H1B Sponsorship
Syneos Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (35)
2024 (26)
2023 (49)
2022 (63)
2021 (84)
2020 (63)
Funding
Current Stage
Public CompanyTotal Funding
$524.65M2023-09-28Private Equity
2023-05-10Acquired
2021-03-01Post Ipo Secondary· $524.65M
Leadership Team
Costa Panagos
Chief Executive Officer
Michael Bonello
Executive Vice President and Chief Financial Officer
Recent News
2026-01-09
2025-12-01
Company data provided by crunchbase