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    Sr Argus Systems Specialist

    Syneos Health
    2+ years
    Not Disclosed
    Remote, USA
    10 Oct. 29, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

    Company Overview
    Syneos Health® is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success. We transform unique clinical, medical affairs, and commercial insights into actionable outcomes that address modern market realities.

    Our Clinical Development model centers on the customer and the patient. We are constantly seeking ways to simplify and streamline our processes, making Syneos Health easier to work with and for.

    Whether you join us in a Functional Service Provider partnership or in a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. Our agility drives the rapid delivery of therapies because we are dedicated to changing lives.

    Why Syneos Health?
    We are passionate about developing our people through career advancement, supportive management, technical training, peer recognition, and a comprehensive rewards program. Our Total Self culture encourages authenticity and unity, ensuring that everyone feels they belong.

    Job Responsibilities

    General Duties:

    • Develop and maintain a repository for relevant documents (Training, Safety and Pharmacovigilance Project Finance, Proposals tracking, etc.).
    • Create and maintain Job Aids and process documents, ensuring supporting documentation is up to date.
    • Stay informed on FDA/EU/ICH guidelines and regulations regarding safety and PV reporting.
    • Collaborate with operational SPVG team members and Therapeutic BU PMs to facilitate accurate revenue recognition.
    • Provide SPVG metrics at agreed intervals based on assigned tasks.
    • Perform other related duties as assigned.
    • Minimal travel may be required (up to 15%).

    Technology Responsibilities:

    • Configure, administer, and maintain the Argus Safety database for project-specific requirements.
    • Participate in audits and conduct system demonstrations as needed.
    • Involve in the implementation and validation of Safety Systems projects, including testing and documentation.
    • Assist in developing and maintaining departmental SOPs and WIs related to Safety Systems.
    • Analyze programs for regulatory and customer reporting needs from Safety Systems.
    • Implement efficiencies in Safety and Pharmacovigilance processes.
    • Participate in the development, validation, and maintenance of Safety reporting tools.
    • Create and maintain Argus Project Information, User Access, and Report Request forms.
    • Troubleshoot issues related to Argus and other Safety systems.
    • Develop training materials for end users and mentor junior Safety Application Specialists.
    • Advise on the use of alternate sponsor databases.
    • Ensure compliance with SOPs, WIs, and global regulations.
    • Participate in planning and executing Safety System Data Migrations and custom reports.
    • Generate and quality-check reports and queries from the safety database for various uses.
    • Represent the Safety Applications team at project and client meetings.
    • Maintain expertise in Safety & PV systems through ongoing education and professional development.

    Qualifications

    What We’re Looking For:

    • Bachelor’s degree in life science, nursing, pharmacy, computer science, or a related field, or equivalent experience.
    • Experience with Safety Database systems and moderate medical terminology.
    • Extensive clinical research experience or related work in the pharmaceutical or CRO industry preferred.
    • Proficiency in relational databases, with preferred experience in Oracle Insight/Analytics/Data Mart and SQL.
    • Strong knowledge of ICH guidelines and regulations related to safety and pharmacovigilance.
    • Proficiency in Microsoft Office Suite (Word, Excel, Visio, PowerPoint) and email applications.
    • Ability to work independently and in a team environment.
    • Strong organizational, communication, and documentation skills.
    • Detail-oriented with the ability to meet deadlines and manage multiple priorities.
    • Minimal travel may be required.

    Get to Know Syneos Health
    Over the past five years, we’ve collaborated on 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, across 200+ studies involving over 675,000 trial patients.

    No matter your role, you’ll be encouraged to take the initiative and challenge the status quo in a highly competitive and ever-changing environment. Learn more about Syneos Health.

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