Job Title: Safety & PV Ops Specialist I
Location: [Insert location]
Company: Syneos Health®
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We bring clinical, medical affairs, and commercial insights together to drive outcomes in modern healthcare.
Our mission: Place the customer and patient at the center of everything we do.
Work culture: Total Self culture promoting diversity, inclusion, and authenticity.
Global presence: 29,000 employees across 110 countries.
Why Work Here:
Career development and progression opportunities.
Supportive and engaged management.
Technical and therapeutic training programs.
Peer recognition and total rewards program.
Position Summary
Assists in operational support across multiple areas within the Safety & Pharmacovigilance (SPVG) Business Unit. Supports Safety Project delivery leads with trainings, document management, system setup, and department-level initiatives, including process improvements and tools development.
Key Responsibilities
1. General Operations
Maintain repositories of relevant documents (training, proposals, finance, audits, departmental metrics).
Develop and maintain Job Aids, SOPs, and supporting documentation.
Keep updated on FDA/EU/ICH guidelines related to safety and pharmacovigilance.
Facilitate annual revenue targets and provide SPVG metrics.
Perform other work-related duties as assigned.
Minimal travel (up to 15%).
2. Quality & Compliance
Support Quality Planning: controlled document management, quality metric tracking.
Facilitate Quality Compliance verification and Quality Assurance processes.
Identify and communicate areas of risk; liaise with Corporate Quality Assurance.
Support audit and inspection readiness for safety project teams.
3. Training & Learning
Plan, develop, and deliver training materials for Safety & PV BU.
Oversee Learning Management System (LMS) for Safety & PV.
Develop PV-specific training for accreditation programs.
4. Technology & Systems
Support system audits, demos, implementation, validation, and documentation.
Maintain departmental SOPs and Work Instructions (WIs) related to Safety Systems.
Configure, administer, and maintain the Argus Safety database per project requirements.
Develop, test, and maintain Safety reporting tools (e.g., Business Objects).
Troubleshoot Safety systems issues and advise users on alternate databases.
Train and mentor junior Safety Application Specialists.
Participate in data migrations, custom reports, and project/client meetings.
5. Proposals & Financial Support
Support SPVG annual GP% targets and proposal strategies.
Ensure accurate SPVG budgets, scope, and text in RFP/RFI responses.
Maintain and update template proposal text and slides.
Review project budgets to ensure realistic allocation of hours and resources.
Attend bid defense and project hand-over meetings as needed.
Qualifications
Education: Bachelor’s degree in life sciences, nursing, pharmacy, computer science, or related field; equivalent experience accepted.
Safety database systems experience required; moderate medical terminology knowledge.
Clinical research, data collection, or CRO industry experience preferred.
Strong computer skills; knowledge of relational databases; Oracle Insight/Analytics/Data Mart, SQL Plus, Crystal Reports/Business Objects preferred.
Excellent knowledge of ICH guidelines and safety/PV regulations.
Proficient in Microsoft Office (Word, Excel, PowerPoint, Visio), Outlook, and internet.
Strong communication, presentation, and interpersonal skills.
Detail-oriented, organized, able to prioritize multiple tasks/projects.
Ability to work independently and collaboratively.
Additional Information
Responsibilities may change at the company’s discretion.
Equivalent experience, skills, or education will be considered.
Compliant with local labor laws and ADA accommodations.
Discover Syneos Health:
Over the past 5 years, worked with 94% of Novel FDA-approved drugs, 95% EMA-authorized products, 200+ studies across 73,000 sites, and 675,000+ trial patients.
Apply: [Insert application link]
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