Jobs
>
Cambridge

    TA Safety Science Manager - Cambridge, United Kingdom - Taleo BE

    Taleo BE
    Taleo BE Cambridge, United Kingdom

    3 weeks ago

    Default job background
    Description

    For Current Gilead Employees and Contractors:

    Please log onto your Internal Career Site to apply for this job.

    At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.


    Job Description

    POSITION OVERVIEW:

    You will perform core MSS activities, including signal detection, development of benefit-risk evaluation management plans and risk minimization activities, contributing input into aggregate safety reports, providing MSS input into study-related activities and documents and regulatory submissions, and providing the MSS perspective into PV processes, to ensure these are completed in a timely and quality manner. You will perform some of these responsibilities with close supervision from a more experienced Global TA Safety Scientist or Physician.

    EXAMPLE RESPONSIBILITIES:

    • Supports authoring or otherwise contributes to the preparation of aggregate safety reports and risk management plans (RMPs).
    • Conducts signal detection and evaluation activities for assigned products in collaboration with the Global TA Safety Physician as part of the continuous benefit-risk evaluation throughout the product lifecycle.
    • Supports implementation of decisions from the signal evaluation process, including updates to core safety information, Investigator's Brochure and other key safety documents and deliverables.
    • May contribute to MSS activities and input related to regulatory filings (e.g., Marketing Authorisation Applications[MAAs], New Drug Applications [NDAs], Biologics License Applications [BLAs]), and responses to safety queries from third parties, such as regulatory agencies.
    • May perform safety reviews of clinical trial protocols, Investigator's Brochures, clinical study reports, informed consent forms, and other study related documents.
    • Participates on Global Patient Safety (GLPS) teams, including MSS functional area support in PV audits and inspections.
    • Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

    REQUIREMENTS:

    We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

    U.S. Education & Experience

    • PharmD/PhD in a scientific field.
    • MA/MS/MBA with 4+ relevant years' experience.
    • BA/BS with 6+ years' relevant experience.
    • Experience in drug safety signal detection and benefit-risk evaluation is preferred.
    • Experience working with aggregate safety reports is preferred.

    Rest of World Education & Experience

    BA/ BS or advanced degree in life sciences or related field with some experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment. Or PharmD or PhD in a scientific field.

    Knowledge & Other Requirements

    • Demonstrated ability to be a fast learner.
    • Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
    • Knowledge of worldwide PV regulations is preferred.
    • Knowledge of the drug development process and understanding of and appropriate application of principles, concepts, practices, and standards of Good Clinical Practices (GCP) and Good Pharmacovigilance (GVP).
    • Strong interpersonal skills and understanding of team dynamics.
    • Proven ability to work successfully in a team-oriented, highly-matrixed environment.
    • Demonstrates good analytical thinking skills, attention-to-detail, good communication and writing skills, project management skills and proficiencies with Microsoft Office suite.
    • When needed, ability to travel.

    Equal Employment Opportunity (EEO)

    It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.


    For Current Gilead Employees and Contractors:

    Please log onto your Internal Career Site to apply for this job.

  • AstraZeneca UK

    Medical Science Manager

    3 weeks ago

    AstraZeneca UK Cambridge, Cambridgeshire, United Kingdom

    Here you'll have the opportunity to make a meaningful difference in patients' lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world's most complex diseases. Answer unmet medical needs by pioneering ...

  • AstraZeneca UK

    Medical Science Manager

    3 weeks ago

    AstraZeneca UK Cambridge, United Kingdom Full time

    Here you'll have the opportunity to make a meaningful difference in patients' lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world's most complex diseases. Answer unmet medical needs by pioneering ...

  • Cambridge University Hospital NHS Foundation Trust

    Communications Manager: Science and News

    3 weeks ago

    Cambridge University Hospital NHS Foundation Trust Cambridge, United Kingdom Permanent

    Job summary · To lead the development of a science communications strategy for CUH, which supports the wider communication strategy. You will build strong relationships with scientists and researchers at CUH to create a pipeline of research news stories for our regional and nati ...

  • Cambridge University Hospital NHS Foundation Trust

    Deputy Blood Sciences Manager

    3 weeks ago

    Cambridge University Hospital NHS Foundation Trust Cambridge, United Kingdom Permanent

    Job summary · An exciting opportunity has arisen to join a dynamic Blood Sciences Department as a Deputy Manager responsible for Haematology. · You will play an important role in the operations teams working alongside managers responsible Biochemistry, Specimen Reception, Traini ...

  • Vector Recruitment Limited

    Quality Manager Life Sciences

    4 days ago

    Vector Recruitment Limited Hertfordshire, United Kingdom

    Quality Manager - Life Sciences · Location: South Cambridgeshire · **Salary**: £50k-£70k + excellent benefits · A position has arisen for an experienced Quality Manager to join a rapidly expanding technology development company - specifically to work within the Life Science divis ...

  • taylorollinson Ltd

    Key Account Manager, Life Science

    1 week ago

    taylorollinson Ltd Cambridge, Cambridgeshire, United Kingdom

    Key Account Manager, Life Science (Cambridge) · Location: Cambridge · Salary: Competitive (70K+ OTE Uncapped) · Product range: Molecular biology instrumentation, reagents and consumables · Join a dynamic, global life science leader that is at the forefront of scientific inno ...

  • SelectLeaders

    Director - Project Management - Life Sciences (Permanent)

    4 weeks ago

    SelectLeaders Cambridge, Cambridgeshire, United Kingdom

    BioMed Realty is looking for a Director, Property Management who can manage and oversee the operational and financial performance for a portfolio of commercial lab and office properties ensuring company goals and expectations are met. The successful candidate will be detail and c ...

  • Stem Graduates

    Scientific Technical Marketing Associate

    2 weeks ago

    Stem Graduates Cambridge, United Kingdom

    **Scientific Technical Marketing Associate** · **Job Location**: Cambridge · **Job Salary**: £23,000-£25,000 plus bonus · **Job Type**: Full-time, permanent · **Job Keywords**: Science Graduate Jobs / Scientific Marketing / Marketing Jobs / Biology Jobs / Biochemistry Jobs / Biom ...

  • Resources Group

    Project Manager

    1 week ago

    Resources Group Cambridge, United Kingdom

    **Study Coordinator/Project Manager - Behavioural Science Consultancy** · **c. £35, Month contract); Cambridge/Some Hybrid** · Help coordinate/project manage insights based assignments for this noteworthy Behavioural Science Team - part of a leading consulting firm · In this Stud ...

  • The Royal Society of Chemistry

    Programme Manager

    2 weeks ago

    The Royal Society of Chemistry Cambridge, United Kingdom

    **Contract**: Full-time (35-hour week) fixed-term (18-month) contract · **Location**: Hybrid Cambridge, London and remote home working within the UK · **Salary**: £45,646 - £50,717 per annum plus benefits (2023 salary range) · The Royal Society of Chemistry seeks a programme mana ...

  • University of Birmingham

    Associate Professor

    3 weeks ago

    University of Birmingham University, United Kingdom

    **Position Details** · School of Biomedical Sciences, Institute of Clinical Sciences, College of Medical and Dental Sciences · Location: Huazhong University of Science and Technology (HUST; 华中科技大学), China · Competitive salary and accommodation · Grade: 9 · Full Time · Closing dat ...

  • The Royal Society of Chemistry

    Events Specialist

    2 weeks ago

    The Royal Society of Chemistry Cambridge, United Kingdom

    **Location**: Hybrid Cambridge, London and remote home working within the UK. · **Salary**: £33,960 - £37,733 per annum plus benefits (2023 salary range) · **Position Type**: Permanent, Full-Time · **Closing Date**: 03/01/2023 · The Royal Society of Chemistry has an exciting oppo ...

  • University of Cambridge

    Kavli Centre Engagement Associate

    3 weeks ago

    University of Cambridge Cambridge, United Kingdom

    The Kavli Centre for Ethics, Science, and the Public in the Faculty of Education at the University of Cambridge wishes to appoint a full-time Engagement Associate to help us amplify our core belief that 'Science is everywhere, and science is for everyone'. As our Engagement Assoc ...

  • AstraZeneca

    Associate Director, Data Product

    1 week ago

    AstraZeneca Cambridge, United Kingdom

    **About AstraZeneca** · At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to co ...

  • University of Cambridge

    Iccs Programme Administrator

    3 weeks ago

    University of Cambridge Cambridge, United Kingdom

    The Institute of Computing for Climate Science (ICCS) studies and supports the role of software engineering, computer science, artificial intelligence, and data science within climate science. · We are looking for an enthusiastic and motivated individual to join the Institute of ...

  • University of Birmingham

    Assistant Professor

    3 weeks ago

    University of Birmingham University, United Kingdom

    **Position Details** · Institute of Clinical Sciences, School of Biomedical Sciences, College of Medical and Dental Sciences · Location: Huazhong University of Science and Technology (HUST; 华中科技大学), China. · Competitive salary and accommodation · Grade 8 · Full Time · Closing dat ...

  • University of Cambridge

    Accounts Assistant

    2 weeks ago

    University of Cambridge Cambridge, United Kingdom

    The Faculty Accounts Office is seeking an Accounts Clerk to assist in the administration of accounts and maintain financial records within the Faculty of Human, Social and Political Sciences and the Dept. of the History and Philosophy of Science in order to contribute to the mana ...

  • The Royal Society of Chemistry

    Member Recruitment Executive

    2 weeks ago

    The Royal Society of Chemistry Cambridge, United Kingdom

    **Location**: Cambridge · **Salary**: £33,960 - £37,733 per annum plus benefits · **Position Type**: Full-Time, Permanent · **Closing Date**: 06/02/2023 · The Royal Society of Chemistry has a great opportunity for a Membership Recruitment Executive to join us on a permanent basis ...

  • Stephen Perse Foundation Senior School

    Head of Computer Science

    3 weeks ago

    Stephen Perse Foundation Senior School Cambridgeshire, United Kingdom

    **Responsible to**:Head of Maths and Computing Faculty, Deputy Head Academic · **Location**:Senior School and Sixth Form · **Role Description**: · To take responsibility for the leadership and management of the Computer Science Department on a fixed term basis, and support the He ...

  • University of Cambridge

    Educational Technologist

    3 weeks ago

    University of Cambridge Cambridge, United Kingdom

    This is an exciting opportunity to become the Educational Technologist in the School of Biological Sciences. In this role you will provide technical support and guidance to enable the delivery of technology-enabled teaching, ensuring that academics and teachers maximize the poten ...