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    Sr Argus Systems Specialist

    Syneos Health
    3+ years
    Not Disclosed
    Poland
    10 Nov. 26, 2024
    Job Description
    Job Type: Remote Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Senior Safety & Pharmacovigilance (PV) Operations Specialist
    Syneos Health®

    Syneos Health is a leading, fully integrated biopharmaceutical solutions organization committed to accelerating customer success. By combining clinical, medical, and commercial insights, we drive results that address modern market challenges.

    Our patient-centered Clinical Development model focuses on simplifying and streamlining processes, making Syneos Health easier to work with and a more rewarding place to work for. Whether you're joining us in a Functional Service Provider (FSP) role or a full-service environment, you’ll work alongside passionate problem solvers to help our customers achieve their goals. We are driven to accelerate the delivery of therapies because we are passionate about changing lives.

    With 29,000 employees across 110 countries, WORK HERE MATTERS EVERYWHERE.

    Why Syneos Health

    We’re committed to developing our people by offering career growth, continuous training, recognition, and a robust rewards program. Our Total Self culture encourages individuality and inclusion, ensuring that everyone can authentically be themselves. We believe that by embracing diverse backgrounds and perspectives, we can create a company where all employees feel valued and empowered.

    Role Overview

    As a Senior Safety & Pharmacovigilance (PV) Operations Specialist, you will play a pivotal role in managing safety systems and ensuring compliance with regulatory standards. Your expertise will help streamline operational processes and ensure safety and pharmacovigilance (PV) procedures are optimized.

    Key Responsibilities

    General Operations:

    • Create and maintain comprehensive repositories for all relevant project documents (e.g., safety and pharmacovigilance training materials, project finance reports, proposals, audits, and inspection records).
    • Develop job aids, process documents, and maintain supporting documentation as needed.
    • Stay informed on FDA/EU/ICH guidelines related to safety and pharmacovigilance reporting.
    • Work with operational teams and project managers to ensure accurate and timely recognition of project revenue and SPVG targets.
    • Provide regular SPVG metrics updates and support reporting at defined intervals.
    • Perform other duties as assigned with minimal travel (up to 15%).

    Technology & Safety Systems:

    • Administer, configure, and maintain the Argus Safety database on a per-project basis to meet sponsor-specific needs.
    • Participate in audits and system demos, supporting safety system implementations and validations.
    • Help develop and update departmental Standard Operating Procedures (SOPs) and Work Instructions (WIs) related to safety systems.
    • Troubleshoot and resolve issues related to Argus and other safety systems.
    • Assist in creating training materials and mentor junior Safety Application Specialists.
    • Ensure compliance with SOPs, global drug/biologic/device regulations, GCP, ICH guidelines, and the drug development process.
    • Generate and quality-check reports, listings, and queries for internal, regulatory, or client use.
    • Represent the Safety Applications team in project and client meetings.
    • Maintain up-to-date knowledge of safety and pharmacovigilance systems through internal meetings, professional seminars, and workshops.

    Qualifications

    Required Skills & Experience:

    • Bachelor’s degree in life sciences, nursing, pharmacy, computer science, or a related technical field, or equivalent combination of education and experience.
    • Proficiency in safety database systems and medical terminology.
    • Solid experience in clinical research, data collection, and computer systems, with a deep understanding of pharmaceutical or CRO industry standards.
    • Advanced computer skills, including experience with relational databases, Oracle Insight/Analytics, Crystal Reports/Business Objects, and SQL Plus.
    • In-depth knowledge of ICH guidelines and safety/pharmacovigilance regulations.
    • Proficient in Microsoft Office Suite (Word, Excel, Visio, PowerPoint), email (Outlook), and internet tools.
    • Strong organizational, communication, and interpersonal skills.
    • Ability to prioritize and manage multiple tasks effectively.
    • Strong attention to detail with high accuracy and ability to meet deadlines.
    • Ability to make sound decisions and handle competing priorities.

    Preferred Skills & Experience:

    • Familiarity with Argus Safety and other safety databases (e.g., ArisG, Clintrace).
    • Experience with business intelligence tools (e.g., Business Objects, Crystal Reports).
    • Mentoring or training experience.

    Join Syneos Health

    At Syneos Health, we’ve supported the approval of 94% of all Novel FDA-approved drugs and 95% of EMA-authorized products, contributing to over 200 studies across 73,000 sites and 675,000+ trial patients. No matter your role, you’ll be part of a team that challenges the status quo in a highly competitive, fast-paced environment.

    Note: This job description is not exhaustive and may be subject to changes at the company's discretion. Equivalent experience, skills, and education may be considered.

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