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Copenhagen

    Senior Manager, Global Drug Safety - Copenhagen, Danmark - Genmab

    Genmab
    Genmab Copenhagen, Danmark

    for 6 dage siden

    Genmab background
    Fuldtid
    Beskrivelse

    The Role

    & Department
    A member of the Global Drug Safety & Pharmacovigilance team, focused on safety operations including but not limited to collection of safety information from various sources, SAE reconciliation, quality control of safety data entry, and compliance of individual case safety reports (ICSRs) to regulatory authorities and business partners.


    Key responsibilities include

    • Oversee the successful and timely case intake of safety reports and case processing
    • Perform ongoing and real-time quality control review of safety case data entry in the safety database in compliance with the data entry conventions and MedDRA/WHO DD coding conventions
    • Provide guidance on questions around safety operations based on not only company conventions, but also ICH and regulatory guidance as well as the best PV practices. Safety operation related questions include but not limited to: case processing; regulatory submissions of Individual Case Safety Reports to regulatory authorities, ethics committees, investigators, and other stakeholders; data entry or safety queries; collection of safety information
    • Develop or update Standard Operating Procedures, Working Instructions, and training materials around safety case processing and operations
    • Oversee and manage SAE Reconciliation activities including review and approval of the reconciliation plan and generation of SAE reconciliation listings
    • Effectively manage safety case workload to ensure compliance with regulatory submissions and internal timelines
    • Perform investigation of deviations and monitoring of Corrective Actions/Preventive Actions (CAPAs) relating to non-compliance issues and findings, as well as assess the effectiveness of the CAPAs
    • Oversee open and answered safety queries in the EDC and timely resolution of safety queries
    • Review and provide input on Safety Operational Management Plan on behalf of Safety Operations
    • Perform User Acceptance Test (UAT) on Safety Related Forms in EDC, ensuring correct dynamics and edit checks
    • Provide comments on the e-Safety Reporting Form Specifications document and perform UAT
    • Generate aggregate and ad-hoc reports for responsible products
    • Oversee other activities related safety operations including ICSR submission or distribution to ECs/IRBs/Investigators/Business Partners
    • Other activities, as needed or as requested by supervisor

    Requirements

    • Drug Safety professional with minimum 5 years of experience within drug safety and PV inclusive of case quality control and regulatory submissions of ICSRs worldwide
    • Good knowledge of ICH E2B(R2) and (R3) specifications and entry guidance
    • Ability to interpret health and medical records such as adverse event reporting forms, a discharge summary, etc
    • Good knowledge of pharmacovigilance reporting rules and timelines
    • Experience with clinical and post-marketing case processing, including MedDRA and WHO DD coding and narrative writing
    • Experience with safety database; Argus is a plus but not mandatory
    • Experience with EDC for clinical trial data collection
    • Analytic and strategic thinking
    • Excellent in detailed-oriented tasks

    This role is located in Copenhagen, Denmark and is hybrid.

    About You

    • You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
    • You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
    • You are a generous collaborator who can work in teams with diverse backgrounds
    • You are determined to do and be your best and take pride in enabling the best work of others on the team
    • You are not afraid to grapple with the unknown and be innovative
    • You have experience working in a fast-growing, dynamic company (or a strong desire to)
    • You work hard and are not afraid to have a little fun while you do so

    Locations

    Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

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