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Safety Scientist

Employer
ICON Strategic Solutions
Location
United Kingdom, Homeworking
Salary
Competitive
Start date
15 Mar 2023
Closing date
14 Apr 2023

View more

Discipline
R & D , Pharmacology
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Key Accountabilities/Responsibilities:
  • Global oversight of safety risk management activities for assigned product(s) including clinical safety,
    signal detection, signal management, aggregate reports, risk communication, risk mitigation and risk
    management.
  • Accountability to lead, in a cross-functional structure. Lead the development and maintenance of
    benefit risk assessments, safety risk management strategies and safety signal detection and
    assessment activities for assigned products.
  • Providing strategic safety leadership for assigned product(s) across various cross-functional teams and
    governance bodies (e.g. Safety Review Committee).
  • Collaborating with stakeholders within the company(e.g. Regulatory Affairs, QPPV, clinical development) and outside of the company (e.g. Key Opinion Leaders and regulators) to ensure the safe use of company products.
  • The patient safety forproducts/compounds and maintenance of compliance with the
    Pharmacovigilance regulations of Regulatory Agencies around the globe through the effective and
    timely completion of PV Assessment activities through product development, product maintenance
    and life cycle management.
  • Representing all activities related to pharmacovigilance, clinical safety, risk management and signal
    detection, and reporting back relevant information regarding status, issues, challenges.
  • Accountability and leading, in a matrix structure, the Benefit and Risk activities and ensuring signal
    detection, risk management, mitigation plans, safety analyses in aggregate reports. As well as scientific
    review of safety related information within in time lines and accuracy of the safety information in
    responses to Health Authorities, product labelling and investigator brochures.

  • MD/DO/PhD/PharmD qualification or the equivalent.
  • Substantial experience within the pharmaceutical industry. Along with a good understanding of the
    global pharmacovigilance and safety requirements for the registration process and onto the market
    with minimum 7 years of relevant experience.
  • Strong personal leadership and communication skills and the ability to lead a multifunctional team.
  • Strong scientific and analytic skills with an ability to provide interpretation and an assessment of
    complex data.
  • Good knowledge of relevant regulations and proven evidence of effective delivery of high quality
    documents as well as relevant concepts in data management and systems, epidemiology and
    statistics.
  • Ability to act without oversight in most circumstances as well as provide key input to difficult or
    sensitive projects.
  • The technical skills and capabilities to author and contribute to large complex documents within
    document management systems and the knowledge of relevant concepts in pharmacovigilance.
  • Be able to identify risks and propose corrective actions in complex and critical situations and the
    ability to a multifunctional team as well basic project management skills to allow management and
    delivery of multiple complex deliverables within tight timelines.
  • Have a good knowledge of GVP and relevant legislations and guidelines.

    Benefits of Working in ICON:

    Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

    At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

    ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

    If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Company

As the largest global provider of Functional Service Provision (FSP) with over 90 partnerships and 14,000+ employees, we have deployed FSP solutions across all major functions, from clinical monitoring and project management through data management, statistical programming, and beyond.

ICON Strategic Solutions teams are embedded in our clients' businesses, working as a dedicated resource within some of the world’s leading Pharmaceutical & Biotech companies. You will play a key role in helping to deliver cutting-edge research, working on novel therapies that deliver real impact.

Why choose a career with ICON Strategic Solutions?

Meaningful Work: You’ll contribute to cutting-edge projects that have a real impact on global healthcare. Your work will play a pivotal role in shaping the future of medicine and improving patient lives.

Collaborative Environment: We foster a collaborative and inclusive work culture that thrives on teamwork, diversity, and knowledge sharing. You'll have the opportunity to collaborate with industry-leading experts, learning from their experiences and growing both professionally and personally.

Innovative Technologies: At ICON Strategic Solutions, we embrace the latest technologies and tools to enhance our capabilities. You'll have access to state-of-the-art software and resources, empowering you to deliver high-quality results efficiently.

Career Growth: We value our employees and invest in their professional development. You'll have access to comprehensive training programs, mentorship opportunities, and a clear career progression path. We believe in recognizing and rewarding exceptional performance, providing ample scope for advancement within the organization.

Global Reach: Joining ICON Strategic Solutions means being part of a truly global company. With service capabilities in 92 countries, you'll have the chance to collaborate with colleagues from diverse backgrounds and gain exposure to projects with a global reach.

Company info
Website

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