Job Title: Safety & PV Ops Specialist I
Location: [Specify Location]
Company: Syneos Health®
Company Overview
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By translating unique clinical, medical affairs, and commercial insights into actionable outcomes, we address modern market realities.
Our Clinical Development model places the customer and patient at the center of everything we do. We continuously strive to simplify and streamline processes, making Syneos Health easier to work with and for.
Whether joining in a Functional Service Provider (FSP) partnership or a Full-Service environment, you will collaborate with passionate problem solvers, innovating to help our customers achieve their goals. Our agile approach is driven by the mission to accelerate therapy delivery and positively change lives.
Join our 29,000 employees across 110 countries who already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health?
Career development, technical and therapeutic area training, and peer recognition programs.
Supportive and engaged management fostering Total Self culture – encouraging authenticity and inclusivity.
Commitment to diversity of thought, background, and perspective to create a sense of belonging for all employees.
Position Summary
The Safety & PV Ops Specialist I provides operational support across multiple areas within the Safety & Pharmacovigilance (SPVG) Business Unit. This role supports Safety Project delivery leads in managing trainings, documentation, system setup, and access requests, while also contributing to process improvement initiatives and department-level tools development. Minimal travel may be required (up to 15%).
Key Responsibilities
General Operations
Maintain a repository of relevant documents, including training materials, SPVG project finance, proposals, RFI library, audits/inspection lists, and departmental metrics.
Develop and maintain job aids, process documents, and supporting documentation.
Stay up-to-date on FDA/EU/ICH guidelines and regulations related to safety and pharmacovigilance reporting.
Support SPVG revenue targets by assisting operational team members and BU leadership.
Provide SPVG metrics and perform additional duties as assigned.
Quality & Compliance
Support quality planning through controlled document management and development of department/client-specific documents.
Track and communicate quality metrics to monitor team and individual performance.
Facilitate quality assurance by identifying and communicating areas of risk.
Liaise with management and Corporate Quality Assurance (CQA) to resolve open Quality Issues (QIs).
Support audit and inspection readiness of Safety project teams.
Training & Learning
Plan, develop, track, and present training materials for the Safety & Pharmacovigilance BU.
Collaborate with leadership to develop PV-specific training for accreditation programs.
Oversee Learning Management System (LMS) activities and training compliance.
Technology & Systems Support
Participate in system audits, demos, implementation, validation, and testing.
Maintain departmental SOPs and Work Instructions (WIs) related to Safety Systems.
Configure, administer, and maintain the Argus Safety database and other sponsor-specific systems.
Troubleshoot Safety systems and support end-user training and mentoring of junior specialists.
Support Safety System data migrations, report generation, and quality checks for internal, client, or regulatory purposes.
Proposals & Financial Support
Support SPVG Gross Profit targets by collaborating with operational teams.
Develop proposal strategy, review scope and budgets, and maintain proposal templates and slides.
Assist with RFPs/RFIs and Plan Activation Strategy calls, ensuring accuracy of budget, text, and scope of work.
Participate in bid defense and project handover meetings as needed.
Required Qualifications
Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Computer Science, Technology, or equivalent combination of education and experience.
Knowledge of Safety Database systems and moderate medical terminology.
Experience in clinical research, data collection, or related computer systems in pharmaceutical/CRO industry preferred.
Strong understanding of ICH guidelines, GCP, and global drug/biologic/device regulations.
Excellent computer skills, including relational databases; experience with Oracle Insight/Analytics, Crystal Reports, Business Objects, SQL Plus preferred.
Proficiency in Microsoft Office Suite (Word, Excel, Visio, PowerPoint), Outlook, and internet.
Excellent organizational, documentation, communication, and interpersonal skills.
Ability to prioritize tasks, manage multiple projects, and work independently or in a team environment.
Detail-oriented with a high degree of accuracy and ability to meet deadlines.
Additional Information
Tasks and responsibilities are not exhaustive; the company may assign other duties as needed.
Equivalent experience, skills, or education will be considered.
Compliant with the Americans with Disabilities Act; reasonable accommodations provided when appropriate.
About Syneos Health Impact
Supported 94% of all novel FDA-approved drugs and 95% of EMA authorized products in the past 5 years.
Contributed to over 200 studies across 73,000 sites and 675,000+ trial patients.
Explore more: Syneos Health
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