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    Sr. Safety & Pv Systems Specialist

    Syneos Health
    2+ years
    Not Disclosed
    Remote - Europe
    10 July 22, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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 & PV Operations Specialist

    About Syneos Health®: Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We leverage clinical, medical affairs, and commercial insights to address modern market realities. Our Clinical Development model centers around our customers and patients, striving for simplicity and efficiency in our operations, making us an easy partner to work with and work for.

    Whether you join us through a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem-solvers. We innovate as a team to help our customers achieve their goals, driven by our commitment to accelerating the delivery of therapies and changing lives.

    Why Syneos Health: At Syneos Health, we are passionate about developing our people through career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and a total rewards program. Our Total Self culture, where you can authentically be yourself, unites us globally. We are dedicated to taking care of our people, fostering an environment where diversity of thoughts, backgrounds, cultures, and perspectives is embraced, making everyone feel like they belong.

    Job Responsibilities:

    General:

    • Develop and maintain a repository of all relevant documents, including training, Safety and Pharmacovigilance (SPVG) project finance, proposals tracking, RFI library, departmental metrics, and audit/inspection lists.
    • Create and maintain Job Aids and process documents, ensuring supporting documentation is up-to-date.
    • Stay informed of applicable FDA/EU/ICH guidelines and regulations related to safety and PV reporting.
    • Work with SPVG team members and Therapeutic BU PMs/Project Directors to facilitate SPVG annual revenue targets and ensure accurate and timely recognition in RBB.
    • Provide SPVG metrics as appropriate based on assigned tasks.
    • Perform other work-related duties as assigned.
    • Minimal travel may be required (up to 15%).

    Technology:

    • Participate in audits and perform system demos as needed.
    • Engage in the implementation, validation, testing, and documentation of Safety Systems projects.
    • Develop and maintain departmental Standard Operating Procedures (SOPs) and Work Instructions (WIs) related to Safety Systems.
    • Analyze and assist with internal and external regulatory or customer report needs from Safety Systems.
    • Implement departmental efficiencies related to Safety and Pharmacovigilance processes.
    • Configure, administer, and maintain the Argus Safety database on a per-project basis to meet sponsor-specific requirements.
    • Participate in the development, validation/testing, and maintenance of all Safety reporting tools (e.g., Business Objects).
    • Create and maintain Argus project information, product/licenses, user access, and report request forms.
    • Troubleshoot issues regarding Argus and other Safety systems.
    • Develop training materials for end-users and functional area trainers on Safety Systems and Argus.
    • Train and mentor junior Safety Application Specialists.
    • Advise and assist Safety users with alternate sponsor databases (e.g., ArisG, Clintrace, Sponsor Argus systems).
    • Ensure compliance with SOPs, WIs, global drug/biologic/device regulations, GCP, ICH guidelines, and the drug development process.
    • Participate in the planning, writing, and execution of Safety System Data Migrations and custom reports.
    • Generate and quality-check listings, reports, and queries from the safety database for internal, client, or regulatory use.
    • Represent the Safety Applications team at project team and client meetings.
    • Maintain expertise in Safety & PvG systems and applications through internal meetings and professional seminars/workshops.

    Qualifications:

    • Bachelor's degree in life sciences, registered nurse, pharmacist, computer science, or a technology-related field, or an equivalent combination of education and experience.
    • Proficiency with Safety Database systems and moderate medical terminology.
    • Extensive clinical research work, data collection/computer systems, or equivalent experience, including understanding and application of principles, concepts, practices, and standards in the pharmaceutical or CRO industry.
    • Strong computer skills and knowledge of relational databases. Preferred experience with Oracle Insight/Analytics/Data Mart, Crystal Reports/Business Objects, and SQL Plus.
    • Excellent knowledge of ICH guidelines and regulations relating to safety and pharmacovigilance.
    • Proficiency in Microsoft Office Suite (Word, Excel, Visio, and PowerPoint), email (Outlook), and internet.
    • Ability to work independently and as part of a team.
    • Ability to prioritize and manage multiple tasks and projects successfully.
    • Excellent communication, presentation, and interpersonal skills, both written and spoken.
    • Strong organizational and documentation skills, with attention to detail and accuracy.
    • Effective decision-making and multi-priority management.
    • Minimal travel may be required.

    Get to Know Syneos Health: In the past five years, Syneos Health has collaborated on 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites and 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.

    Additional Information: Tasks, duties, and responsibilities listed in this job description are not exhaustive. The company may assign other tasks, duties, and job responsibilities at its sole discretion. Equivalent experience, skills, and/or education will also be considered. The company will determine what constitutes equivalent qualifications. This job description should not be construed as an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. This language is intended to comply with all obligations imposed by legislation in each country in which the company operates, including the EU Equality Directive. The company is committed to compliance with the Americans with Disabilities Act, including providing reasonable accommodations when appropriate to assist employees or applicants in performing the essential functions of the job.

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