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    Manager - Regulatory Affairs - Cambridge, Cambridgeshire, United Kingdom - Vertex Ventures HC

    Vertex Ventures HC
    Vertex Ventures HC Cambridge, Cambridgeshire, United Kingdom

    2 weeks ago

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    Description
    BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines.

    Our pipeline includes Bicycle Toxin Conjugates as well as fully synthetic Bicycle systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications with high unmet medical need.

    Bicycle is headquartered in Cambridge, UK, and our US operations run out of Lexington, MA.
    We have a new opportunity within our Drug Safety function for a Manager, Drug Safety.
    This roleprovides clinical safety and pharmacovigilance support to medicines across life-cycle.

    Reporting to the Head of Drug Safety, you will oversee the drug safety operation and compliance activities for the development programmes and ensuring inspection readiness.

    Serve as the main point of contact for the drug safety operation activities in liaison with external clinical trial vendors and internal cross functional teams.

    Responsible for maintaining and oversight of regulatory safety reporting compliance.
    Effective monitoring and tracking of serious adverse events (SAEs), SUSARs and aggregate reports, including scientific literature.

    Oversight & tracking of reconciliation of SAEs between clinical and safety database in close collaboration with data manager and trial CROs, and escalate any issues for prompt resolution.

    Laise closely with the Bicycle quality function and act as drug safety point of contact for inspection readiness initiatives, and effective participation in CAPA generation as required.

    Provide input and track the generation of project specific plans such as but not limited to Safety Management Plans (SMP) or SAE Reconciliation plans, in close cooperation with project team during set-up and maintenance phase
    In liaison with external vendors, maintain trial master file for safety related documentation in a timely manner
    Responsible for departmental initiatives, set up processes & tools for regulatory compliance tracking and effective monitoring. Lead investigation of drug safety process related issues as appropriate.
    Support safety surveillance activities, and act as back to team members.
    Assists with development and maintenance of Bicycle Drug Safety SOPs.
    Monitors assigned project to assure company quality and associated project goals and objectives are being met
    Experiencewithinin drug safety and pharmacovigilance including project management in the pharmaceutical industry/CROs
    Experience with use of safety databases, preferably Argus but not compulsory
    Proficiency in standard desktop software programs (Word, Excel, PowerPoint, Outlook)
    State-of-the-art campus environmentwith on campus restaurant and Montessori nursery
    ~ Flexible working environment
    ~ Competitive reward including annual company bonus
    ~28 days annual leave in addition to bank holidays+ option to buy up to 5 additional days annually
    ~ Employer contribution to pension (employee does not have to contribute)
    ~ Life assurance cover 4x basic salary
    ~ Private Medical Insurance, including optical and dental cover.
    ~ Employee assistance program
    ~ Health Cash Plan
    ~ Access to company subsidized gym membership.
    ~ Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.
    ~ Cycle to work scheme

    Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve.

    Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.

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