Head, Shared Safety Sciences
Stiefel Laboratories, Inc
Middlesex, United Kingdom
23d ago

Your Responsibilities :

GSK is establishing a new department, Shared Safety Sciences, which will provide Safety Evaluation and Risk Management support for GSK’s Established and Generic product portfolios plus enterprise support (Pharma, Consumer, Vaccines) for Literature and Aggregate reports, metrics and other technical support activities.

The Shared Safety Sciences platform will be responsible for clinical safety surveillance activities for approximately 350 pharmaceutical marketed Established products, covering multiple therapeutic areas, including the generics portfolios, plus the delivery of cross business unit pharmacovigilance service activities supporting the entire GSK portfolio of 1000+ products to include Pharma, Vaccines and Consumer Health.

The Head, Shared Safety Sciences will lead the strategy for the creation, implementation and ongoing operations, to include accountability for further expansion subject to performance.

You will lead and manage a team of physicians and scientists in UK / US, Poland and India deployed under a flexible resourcing model.

Critical to your success will be your ability to; identify best safety practices across the business as well as manage key stakeholders external to GSK such as regulators, vendors and industry bodies, thus advancing innovative PV methodology in the external environment.

Key Responsibilities

Create and lead the Shared Safety Sciences department. Create a vision for the group, develop and lead implementation of a strategic plan to deliver on that vision.

Ensure the growing organisation flourishes and drive strategies to develop required workforce capability

Develop and execute the strategy to deliver a range of safety surveillance activities for GSK’s portfolio of 1000+ products, in collaboration with Regulatory and other key GSK stakeholders

Lead Safety Evaluation and Risk Management activities for GSK’s Pharma Established Products, including the Generics portfolio, as defined by relevant procedures

Develop and deliver a combined literature screening service for Individual Case Safety reports (ICSRs) and signal detection, for all GSK business units

Coordinate and deliver medical assessments for Product Incident Review Committees (PIRCs), in collaboration with appropriate Product Specialist support

  • Accountable for Central Safety processes across the PV enterprise, to include leadership of process improvement initiatives, and chair of Central Safety Department (CSD) Operations Board, ensuring compliance with all relevant PV regulations;
  • meet GSK KPIs for regulatory deliverables, and CSD KPIs for internal stakeholders.

  • Drive capability development in Shared Safety Sciences to ensure it is fit for purpose for future growth (e.g. increased scope for Vaccines, expansion of services provided);
  • optimise resource across the platform, to include sites in Bangalore, Hyderabad, Poland, UK and US embracing innovative solutions and technologies where appropriate.

    Drive innovative methodologies in the external PV environment; interact with key external stakeholders such as Regulatory and deliver innovative enhancements to maximise process efficiency and opportunities offered by technological advances, in collaboration with Head, Safety Data Service and other parts of the business

    Deliver Shared Safety Science services which ensure alignment on cross organisational initiatives and activities, whilst meeting expectations of key stakeholders including peers -

    Head of Safety Data Services and Heads of Safety for Pharma, Consumer, Vaccines and ViiV


    Deep understanding and experience of pharmacovigilance.

    Significant leadership and team management experience

    Decision making on (urgent) process / compliance issues

    Regulatory and Medical Affairs interface experience

    Proven track record of creating / leading an organization of motivated, talented individuals who are proficient in the timely delivery of high quality outputs

    To apply, please send your CV and Cover Letter by Monday 13th August 2018

    Basic qualifications :

    BSc or equivalent in Biomedical or Life Sciences.

    Preferred qualifications :

    Masters or Medical degree or Higher professional qualification in pharmacovigilance

    Why GSK? :

    GlaxoSmithKline (GSK) is a science-led, global healthcare company that researches and develops innovative products. GSK currently employ over 100,000 people globally and has offices in more than 115 countries.

    The Company has major research centers in the UK, USA, and Spain, Belgium and China and an extensive manufacturing network with 84 sites globally.

    The Company strategy is focused around growing a diversified global business, delivering more products of value, and simplifying their operating model.

    Being a responsible business is central to the strategy, and how they deliver success is just as important as what they achieve.

    In order to ensure they meet society’s expectations, the company ensures that their values are embedded into the organisation’s culture and decision-

    making. By investing in these areas the Company will increase growth, reduce risk and improve their long-term financial performance.

    GSK is a globally renowned company that owns internationally recognized brands and products. They have a healthy pipeline of innovative products and are well positioned to continue their success into the future.

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