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WD166431 - SERM Director - Oncology

Job Details

  • Permanent, Full Time
  • Middlesex
  • Closes 6th June 2018
  • Requisition ID: WD166431
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Your Responsibilities:

In this job your role will span the work of project and product safety as practiced by Directors in both the GCSP SERM: Development and GCSP SERM: Mature Products groups. Your roles and responsibilities described herein will be performed in partnership with the SDL for assigned products, if an SDL is assigned, as appropriate.

YOU will:
• Provide scientific expertise in the safety evaluation and risk management of key GSK assets or other highly complex products in clinical development and/or the post-marketing setting
•Ensure that adverse event and other safety information is evaluated in order to meet global compliance and regulatory requirements,
• Identify the need for product labelling updates and drive proactive implementation of risk management initiatives

• Safety Governance and Risk Management activities
• Drive pharmacovigilance and risk management planning in the clinical matrix
• Lead production of global Benefit-Risk Management Plans for designated products
• Lead safety input into regulatory benefit-risk assessments
• Prepare the regional Risk Management Plans for designated products for submission to regulatory authorities
• Deliver the clinical safety input into clinical development planning activities
• Represent GCSP on cross functional Clinical Matrix Teams and/or Project Teams.
• Lead cross-functional ad hoc teams to address urgent and important product safety issues
• Review and provide technical approval for investigator brochures, protocols, Informed consents, final study reports and external data monitoring committee charters
• May lead or participate in discussion at Global Safety Board / Consumer Products Safety Board for safety related findings in clinical development.
• Present safety information at clinical investigator and commercial meetings.
• Ensure prompt notification to SERM Head of reviewed protocols that are identified as potential PASS
• Establish and chair the Safety Review Team (SRT) for projects in development
• Provide expert review of data and management of safety issues.
• Escalate safety signals identified through the Safety Review Process to Global Safety Board / Consumer Products Safety Board if necessary, via the SERM Head.
• Ensure that risk reduction strategies are included in relevant documents such as clinical study protocols and/or product labelling, as appropriate
• Signal Detection, Evaluation and Labelling
• Drive signal detection for assigned products using available methodologies (including On-Line Signal Management tool, literature review and tools for individual case awareness).
• Make recommendations to SERM Team Leader for the assessment and prioritisation of safety signals
• Proactively lead the assessment of safety data and discuss the results with the SERM Team Leader/ product physician.
• Communicate with Clinical Development and other key stakeholders on signal evaluation and labelling recommendations
• Lead presentations on labelling recommendations at Global Labelling Committee / Consumer Healthcare Global Labelling Committee or Global Safety Board / Consumer Products Safety Board
• Produce regulatory supporting documentation for labelling updates
• Produce accurate and fit for purpose evaluation documents with clear conclusions, in response to internal or regulatory authority requests for safety data.
• Provide strategic input into regulatory requests for local label deviations from the company core data sheet
• Conduct proactive signal detection and evaluation of issues potentially related to product defects or manufacturing issues;
• Drive the escalation and resolution of issues and product complaints In consultation with the product physician and Clinical Development
• Represen, prepare the Development Core Safety Information (DCSI) for assigned development products;
• Co-ordinate and chair meetings and track timelines to ensure completion of Regulatory Reports and Submissions
• Drive production of periodic regulatory documents (PSURs, DSURs) according to the agreed process and timelines.
• Advise on strategy for the content of high profile PSURs
• Support the Local Operating Companies by preparing license renewal documentation (e.g. PSUR addenda line listings, clinical overviews, summary bridging reports) as required for each market
• Lead the SERM safety component of global regulatory submissions for new products, formulations or indications, with liaison with other functional experts
• Drive the review or production of the SERM component of Safety Data Exchange Agreements and escalate any deficiencies to the SERM Head to ensure quality and integrity of agreement.
• Advise on the preparation of licensing agreements in therapeutic area of responsibility
• Participate in due diligence activities by providing expert safety assessments and recommendation
• Participate in GSK internal or external meetings with project focus, including those with consultants, other companies such as licensing partners and regulatory authorities
• Provide support to GSK Legal for product liability litigation, as appropriate
• Accountable for maintaining personal readiness in response to internal audit or regulatory inspection
• Lead a process improvement initiative within GCSP.
• Contribute to advancement of methodology and process by generating new ideas and proposals for implementation
• Raise concerns/ issues (i.e. sentinel events) to senior management in a timely, open and appropriate manner; ensures quality and integrity of issue/event being escalated
• Train, coache and mentor scientists in the scientific aspects of signal evaluation methodology and risk management and preparation of safety reports and other documents

Why You?

Basic qualifications:

Because, You have:
• A degree in Biomedical or Health Care related speciality
• Expert in evaluation and analytical thinking skills
• Medical writing skills
• Computing skills
• Knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities
• Expertise in causality assessment, evaluation of safety signals and proactive risk management strategies including management of labelling changes, physician and patient education
• Understanding of clinical development process
• Have a proven ability to lead safety evaluation activities,
• Ensure that appropriate safety objectives and risk minimisation strategies are included in clinical development programmes
• Show confidence, credibility and influence at all levels of the organisation
• Present the disease area or product area safety strategy at key internal GSK meetings and
• Represent GSK externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners.

Preferred qualifications:
• Early phase Oncology/product experience
• Knowledge of the therapeutic area of assigned GSK products
• Knowledge of other related disciplines, e.g. statistics, epidemiology relevant to assessing drug utilization and safety at the population level
• Knowledge of medical and drug terminology and a foundation in pharmacology


Why GSK?:
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.

Contact information:
You may apply for this position online by selecting the Apply now button.

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