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    Sr Argus Systems Specialist

    Syneos Health
    3+ years
    Not Disclosed
    Turkey
    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 Operations Specialist
    Syneos Health®

    Syneos Health is a leading biopharmaceutical solutions organization, fully integrated to accelerate customer success. We focus on delivering outcomes through unique insights in clinical, medical affairs, and commercial domains. Our patient-centric Clinical Development model simplifies processes, ensuring we’re not only easier to work with but also a more fulfilling place to work.

    Join us in a dynamic environment, whether in a Functional Service Provider (FSP) partnership or a full-service team, where you’ll collaborate with passionate, solution-driven colleagues to help our customers achieve their goals. We are committed to accelerating therapy delivery, driven by a shared passion to change lives.

    Discover why 29,000 employees across 110 countries already know: WORK HERE MATTERS EVERYWHERE.

    Why Syneos Health

    We are dedicated to fostering career development, offering continuous growth through training, mentoring, and recognition. Our Total Self culture encourages individuality and inclusion, ensuring that everyone feels they belong and thrives. By embracing diverse perspectives, we’re building a company that people want to work for and collaborate with.

    Position Overview

    As a Senior Safety & Pharmacovigilance (PV) Operations Specialist, you will play a key role in managing and optimizing Safety Systems, supporting operational efficiencies, and maintaining compliance with industry standards.

    Key Responsibilities

    General Operations:

    • Develop and maintain repositories for project documentation, including safety and pharmacovigilance-related materials (e.g., training documents, project finance records, departmental metrics, audit/inspection reports).
    • Create and update job aids and process documentation.
    • Ensure compliance with FDA/EU/ICH guidelines related to safety and pharmacovigilance reporting.
    • Collaborate with SPVG operational teams to meet revenue targets and ensure accurate recognition in RBB.
    • Provide regular updates and metrics on assigned tasks and projects.
    • Perform additional work-related duties as needed, with occasional travel (up to 15%).

    Technology and Systems:

    • Configure and manage the Argus Safety database to meet sponsor-specific requirements for each project.
    • Support audits and system demos as needed, and ensure the ongoing validation of Safety Systems.
    • Develop and maintain Standard Operating Procedures (SOPs) and Work Instructions (WIs) for Safety Systems.
    • Troubleshoot and resolve issues related to Argus and other safety systems.
    • Assist with the development of Safety Systems training materials and mentor junior Safety Application Specialists.
    • Support the creation and maintenance of safety-related reports, listings, and queries for internal, regulatory, and client use.
    • Participate in the planning, testing, and execution of safety system data migrations and custom reports.

    Compliance and Documentation:

    • Maintain a thorough understanding of global drug/biologic/device regulations, GCP, ICH guidelines, and the drug development process.
    • Ensure Safety System usage complies with applicable SOPs and WIs.
    • Provide input into the development of tools for internal and external reporting needs related to Safety Systems.

    Qualifications

    Required Skills & Experience:

    • Bachelor’s degree in life sciences, nursing, pharmacy, computer science, or related technical field, or equivalent work experience.
    • Proficient in Safety Database systems and medical terminology.
    • Experience in clinical research, data collection, and understanding of pharmaceutical industry standards.
    • Strong computer skills, with knowledge of relational databases, Oracle Insight/Analytics, Crystal Reports/Business Objects, and SQL Plus preferred.
    • Familiarity with ICH guidelines and regulations related to safety and pharmacovigilance.
    • Proficient in Microsoft Office (Word, Excel, Visio, PowerPoint), Outlook, and internet research.
    • Ability to work independently and collaboratively in a team environment.
    • Excellent organizational, communication, and interpersonal skills.
    • Strong attention to detail, accuracy, and ability to meet deadlines.
    • Ability to manage multiple tasks and prioritize effectively.
    • Minimal travel (up to 15%) may be required.

    Preferred Skills & Experience:

    • Experience with Argus Safety and other safety database systems (e.g., ArisG, Clintrace).
    • Familiarity with business intelligence tools (e.g., Business Objects, Crystal Reports).
    • Experience in mentoring and training junior staff.

    Join Syneos Health

    At Syneos Health, we work with some of the most innovative pharmaceutical companies globally, contributing to the approval of novel drugs and therapies that change lives. Join us in shaping the future of healthcare.

    Note: This job description is not exhaustive and may be updated at the company’s discretion.

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