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    Director, Safety Technology

    Parexel
    12+ years
    Not Disclosed
    Remote, USA
    10 Sept. 26, 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

    Job Opportunity: Safety Technology Leader at Parexel

    About This Role:

    As a leader within Parexel’s Safety and CTS&L Technology organization, you will provide oversight and strategic direction for our Safety Technology team. Your role will involve fostering team development and delivering innovative technology solutions that enhance Parexel’s Safety Operations and support our clients. This includes optimizing processes, focusing on automation and AI, and ensuring quality benchmarks are met in a collaborative environment.

    Key Accountabilities:

    Safety Technology Leadership

    • Lead the planning and delivery of in-house safety technology, including the safety database (currently Oracle Argus Safety SaaS 8.4.1) and Oracle Analytics.
    • Drive initiatives in Safety Analytics and Reporting using tools such as Oracle Analytics, OBIEE, and Power BI.
    • Showcase strong knowledge of Apex Development (ideally in safety solutions) or similar technologies.
    • Focus on automating safety processes and solutions to enhance efficiency.
    • Support and provide input during client audits and regulatory inspections regarding safety technology.
    • Shape the safety systems roadmap and contribute to business case development for new technology solutions.
    • Oversee large technology projects to ensure they are delivered on time and within budget.
    • Serve as a liaison with internal teams and external clients to align programs and processes with contractual and regulatory requirements.

    Staff Management

    • Recruit, retain, and nurture a skilled and motivated team.
    • Foster a positive, results-oriented work environment through effective communication and teamwork.
    • Demonstrate strong leadership skills, participating actively in management meetings and project support.
    • Engage in formal staff reviews, including performance and salary assessments.

    Client Management

    • Ensure that client and business needs are met, optimizing resource allocation for initiatives.
    • Manage relationships with clients and software vendors effectively.
    • Participate in project bids, client presentations, and business review meetings, providing input on resource allocation and pricing.

    Skills:

    • Exceptional interpersonal, verbal, and written communication abilities.
    • Client-focused with strong skills in managing virtual teams and motivating staff.
    • Expert analytical and problem-solving skills, with excellent organizational capabilities.
    • Strong understanding of safety software and systems, with knowledge of emerging pharmacovigilance technologies, including AI.
    • Advanced experience in standard SDLC processes, including change management.
    • Ability to proactively identify new opportunities and learnings, while leading multiple tasks and prioritizing workloads effectively.
    • In-depth knowledge of computer system regulations in the pharmaceutical industry (e.g., 21 CFR Part 11, EMA Annex 11, GAMP).
    • Comprehensive understanding of pharmacovigilance roles, standards, and practices, along with GVP and GCP guidelines.

    Knowledge and Experience:

    • Safety Supportive Applications: 12+ years of experience in safety technology, including Argus and automation-focused tools.
    • Drug Safety and Pharmacovigilance Processes: 12+ years working with operational teams to manage issues and deliver solutions.
    • Process Improvements: 5+ years of experience proposing and delivering system and process enhancements.
    • Leadership Representation: 5+ years acting as a contact point and representative for safety technology in cross-functional teams.
    • Communication Skills: Strong fluency in English, with the ability to create and deliver clear presentations to senior stakeholders and clients.
    • Safety Analytics: 3+ years of experience in driving safety analytics initiatives.
    • Apex Development: 3+ years of experience managing Apex development projects.

    If you are ready to lead the way in safety technology and contribute to our mission at Parexel, we encourage you to apply!

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