Job Title: Safety & PV Ops Specialist I
Company: Syneos Health®
Location: [Insert Location]
About Syneos Health:
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization, accelerating customer success by translating clinical, medical affairs, and commercial insights into outcomes. Our Clinical Development model centers the customer and patient in everything we do. We simplify processes and innovate collaboratively to ensure faster delivery of therapies and improved patient outcomes.
With 29,000 employees across 110 countries, our motto is:
“WORK HERE MATTERS EVERYWHERE.”
Why Syneos Health:
Career development and progression opportunities.
Supportive and engaged line management.
Technical and therapeutic area training.
Peer recognition and total rewards program.
Inclusive Total Self culture promoting authenticity and belonging.
Commitment to diversity of thought, background, and perspective.
Job Summary:
The Safety & PV Ops Specialist I provides operational support across the Safety & Pharmacovigilance (PV) Business Unit (BU). This role assists Safety Project Delivery Leads with trainings, document management, system setup, and access requests, while supporting department-level initiatives, process improvements, and tool development.
Key Responsibilities:
General Operations:
Develop and maintain repositories for training, safety, PV project finance, proposals, RFIs, departmental metrics, and audit/inspection lists.
Create and maintain Job Aids, process documents, and supporting documentation.
Maintain knowledge of FDA, EU, and ICH safety and PV guidelines.
Collaborate with SPVG operational team members and BU PMs/Project Directors to facilitate accurate revenue recognition.
Generate and provide SPVG metrics as required.
Perform other duties as assigned.
Minimal travel (up to 15%) may be required.
Quality & Compliance:
Support quality planning through controlled document management.
Track and communicate quality metrics to assess team performance.
Assist in compliance verification and quality control activities.
Identify and communicate risk areas via risk-based process assessments.
Liaise with management and Corporate Quality Assurance (CQA) to resolve Quality Issues (QIs).
Support audit and inspection readiness of safety project teams.
Training:
Develop, plan, track, and deliver training materials for Safety & PV BU.
Identify content needs in collaboration with PV leadership.
Manage Learning Management System (LMS) oversight.
Create PV-specific training for accreditation programs.
Technology & Systems:
Participate in system audits, demos, implementation, validation, testing, and documentation.
Support development and maintenance of SOPs and Work Instructions for Safety Systems.
Administer Argus Safety database and other sponsor-specific systems.
Develop, test, and maintain Safety reporting tools (e.g., Business Objects).
Troubleshoot issues and assist users with alternate sponsor databases (ArisG, Clintrace, Sponsor Argus).
Train and mentor junior Safety Application Specialists.
Ensure compliance with SOPs, WIs, GCP, ICH, and drug/biologic/device regulations.
Participate in data migrations, custom report creation, and quality checks of listings and queries.
Proposals & Financial Support:
Support SPVG Annual Gross Profit (GP%) targets and proposal development.
Attend Plan Activation Strategy calls; liaise with leadership for proposal content.
Ensure accuracy of budget, scope, and text for RFPs and RFIs.
Maintain proposal templates and SPVG slides.
Support changes in scope or budget with Contracts and Project Managers.
Participate in bid defense and project handover meetings as needed.
Qualifications:
Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Computer Science/Technology, or equivalent experience.
Experience with Safety Database systems and moderate medical terminology.
Knowledge of clinical research, data collection, and CRO/pharmaceutical industry standards preferred.
Proficiency with Microsoft Office Suite, email, and internet.
Strong computer skills and knowledge of relational databases (Oracle Insight/Analytics/Data Mart, Crystal Reports/Business Objects, SQL Plus preferred).
Knowledge of ICH guidelines and global PV regulations.
Excellent communication, presentation, and interpersonal skills.
Ability to prioritize and manage multiple tasks/projects independently and collaboratively.
Detail-oriented with strong organizational and documentation skills.
Minimal travel may be required.
Additional Information:
Tasks and responsibilities are not exhaustive; the company may assign additional duties at its discretion.
Equivalent experience, skills, or education may be considered.
The company is committed to compliance with the Americans with Disabilities Act and will provide reasonable accommodations as needed.
Discover Syneos Health:
Over the past 5 years, we have contributed to 94% of all novel FDA-approved drugs, 95% of EMA-authorized products, and over 200 studies across 73,000 sites and 675,000+ trial patients.
Learn more: Syneos Health
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