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    Sr Safety & Pv Ops Specialist- Argus Administrator

    Syneos Health
    5+ years
    Not Disclosed
    Remote, USA
    10 Oct. 14, 2024
    Job Description
    Job Type: Remote 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

    Position: Senior Safety & Pharmacovigilance (PV) Operations Specialist

    Company Overview: Syneos Health® is a leading biopharmaceutical solutions organization dedicated to accelerating customer success. We prioritize clinical, medical affairs, and commercial insights to address modern market challenges. Our Clinical Development model centers on customers and patients, continuously seeking to simplify and streamline our operations to enhance collaboration and impact.

    Why Join Syneos Health: We are passionate about developing our employees through career advancement opportunities, supportive management, specialized training, peer recognition, and comprehensive rewards programs. Our commitment to a Total Self culture allows individuals to be their authentic selves, fostering a diverse environment where everyone feels valued.

    Key Responsibilities:

    General:

    • Maintain a comprehensive repository of documents related to Training, Safety, Pharmacovigilance Project Finance, proposal tracking, departmental metrics, and audit/inspection lists.
    • Develop and update Job Aids and process documents, ensuring all supporting documentation is current.
    • Stay informed about FDA/EU/ICH guidelines and regulations for safety and PV reporting.
    • Collaborate with operational SPVG teams and Project Directors to facilitate annual revenue targets and ensure accurate financial recognition.
    • Provide relevant SPVG metrics at designated intervals and perform other assigned duties as necessary.
    • Minimal travel required (up to 15%).

    Quality & Compliance:

    • Support Quality Planning activities by managing controlled documents and tracking quality metrics.
    • Facilitate Quality Compliance verification and performance of quality control activities.
    • Identify and communicate risk areas through assessments and provide support for Quality Improvement initiatives.
    • Assist project teams in maintaining readiness for audits and inspections.

    Training:

    • Design, develop, and present training materials for the Safety and Pharmacovigilance Business Unit.
    • Oversee the Learning Management System (LMS) for Safety and Pharmacovigilance.
    • Create specific training for PV accreditation programs.

    Technology:

    • Participate in audits and system demonstrations.
    • Engage in the implementation and validation of Safety Systems projects, ensuring proper documentation and testing.
    • Contribute to the development and maintenance of departmental Standard Operating Procedures (SOPs) and Work Instructions (WIs).
    • Administer and maintain the Argus Safety database for projects, ensuring sponsor requirements are met.
    • Troubleshoot issues related to Safety Systems and assist in developing training materials for end users.
    • Maintain expertise in Safety & PV systems through ongoing professional development.

    Proposals:

    • Collaborate with operational SPVG teams to meet annual Gross Profit percentage targets.
    • Develop proposal strategies in conjunction with SPVG leadership and ensure the accuracy of budget and scope in RFPs and RFIs.
    • Maintain and update proposal templates and costing models to align with project financials.

    Qualifications:

    • Bachelor’s degree in life sciences, nursing, pharmacy, computer science, or a related technical field; equivalent experience will also be considered.
    • Experience with Safety Database systems and medical terminology.
    • Extensive background in clinical research or data management within the pharmaceutical or CRO industry.
    • Proficiency in relational databases, with knowledge of Oracle Insight/Analytics, Crystal Reports/Business Objects, and SQL Plus preferred.
    • Strong understanding of ICH guidelines and regulations for safety and pharmacovigilance.
    • Proficient in Microsoft Office Suite (Word, Excel, Visio, PowerPoint), Outlook, and internet navigation.
    • Ability to work independently and collaboratively in a team environment, managing multiple priorities effectively.
    • Excellent communication, presentation, and interpersonal skills with strong organizational capabilities.

    About Syneos Health: Over the past five years, we have collaborated on 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, contributing to over 200 studies across 73,000 sites and more than 675,000 trial patients.

    Join us at Syneos Health, where your role makes a meaningful impact in a dynamic and competitive environment.

    Additional Information: This job description is not exhaustive, and responsibilities may be adjusted as needed. The company reserves the right to define equivalent experience and qualifications. We are committed to compliance with all relevant employment legislation, including the Americans with Disabilities Act, and will provide reasonable accommodations as required.

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