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    Senior Safety & Pv Operations Specialist

    Syneos Health
    2+ years
    Not Disclosed
    Remote
    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 dedicated to accelerating customer success. We bring clinical, medical affairs, and commercial insights to the forefront, addressing modern market realities.

    Our Clinical Development model prioritizes the customer and the patient. We strive to simplify and streamline processes to enhance both our client relationships and employee experiences.

    Whether you join us as part of a Functional Service Provider partnership or in a Full-Service environment, you’ll collaborate with passionate problem solvers dedicated to innovating and helping customers achieve their goals. Our agility drives the rapid delivery of therapies, fueled by our commitment to changing lives.

    Why Work at Syneos Health?
    At Syneos Health, we are passionate about career development and progression. We offer supportive management, technical training, peer recognition, and a comprehensive rewards program. Our Total Self culture encourages authenticity and unity among our global team, fostering an environment where diversity of thought, background, and perspective is valued.

    Job Responsibilities

    General Duties:

    • Develop and maintain a repository for all relevant documents (Training, Safety and Pharmacovigilance Project Finance, Proposals tracking, etc.).
    • Create and maintain Job Aids and process documents with necessary supporting documentation.
    • Stay updated 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 and timely revenue recognition.
    • Provide SPVG metrics as required.
    • 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 system demonstrations.
    • 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 report needs from Safety Systems.
    • Enhance departmental efficiencies in Safety and Pharmacovigilance processes.
    • Develop, validate, and maintain 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 train junior Safety Application Specialists.
    • Assist with data migrations and custom reports.
    • Generate quality-checked listings and reports from the safety database for internal and regulatory use.
    • Represent the Safety Applications team at project and client meetings.
    • Maintain expertise in Safety & PV systems through ongoing education and professional development.

    Qualifications

    Required Skills and Experience:

    • Bachelor’s degree in life science, nursing, pharmacy, computer science, or a related field, or equivalent experience.
    • Experience with Safety Database systems and familiarity with medical terminology.
    • Extensive clinical research experience or related work in the pharmaceutical or CRO industry.
    • Proficiency in relational databases, with preferred experience in Oracle Insight/Analytics/Data Mart and SQL.
    • Knowledge of ICH guidelines and regulations concerning safety and pharmacovigilance.
    • Proficient in Microsoft Office Suite and email applications.
    • Ability to work independently and as part of a team.
    • Strong organizational and documentation skills, with a detail-oriented approach.
    • Excellent communication and presentation skills.
    • Capable of managing multiple priorities and making effective decisions.

    About Syneos Health
    In 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 675,000+ trial patients.

    Join us at Syneos Health to challenge the status quo and make a meaningful impact in a dynamic environment.

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