Provides high level 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
Ensures that adverse event and other safety information is efficiently 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
Has a proven ability to lead safety evaluation activities, ensures that appropriate safety objectives and risk minimisation strategies are included in clinical development programmes and shows confidence, credibility and influence at all levels of the organisation
Presents the disease area or product area safety strategy at key internal GSK meetings and represents GSK externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners.
Safety Governance and Risk Management activities
Drives pharmacovigilance and risk management planning in the clinical matrix and leads production of global Benefit-Risk Management Plans for designated products Leads safety input into regulatory benefit-risk assessments, prepares the regional Risk Management Plans for designated products for submission to regulatory authorities Delivers the clinical safety input into clinical development planning activities Represents GCSP on cross functional Clinical Matrix Teams and/or Project Teams. Leads cross-functional ad hoc teams to address urgent and important product safety issues Reviews and provides 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. Presents safety information at clinical investigator and commercial meetings. Ensures prompt notification to SERM Head of reviewed protocols that are identified as potential PASS Establishes and chairs the Safety Review Team (SRT) for projects in development and provides expert review of data and management of safety issues. Escalates safety signals identified through the Safety Review Process to Global Safety Board / Consumer Products Safety Board if necessary, via the SERM Head. Accountable for ensuring 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
Drives signal detection for assigned products using available methodologies (including On-Line Signal Management tool, literature review and tools for individual case awareness). Makes recommendations to SERM Team Leader for the assessment and prioritisation of safety signals Proactively leads the assessment of safety data and discusses the results with the SERM Team Leader/ product physician. Effectively communicates with Clinical Development and other key stakeholders on signal evaluation and labelling recommendations Leads presentations on labelling recommendations at Global Labelling Committee / Consumer Healthcare Global Labelling Committee or Global Safety Board / Consumer Products Safety Board Produces regulatory supporting documentation for labelling updates Produces accurate and fit for purpose evaluation documents with clear conclusions, in response to internal or regulatory authority requests for safety data. Provides strategic input into regulatory requests for local label deviations from the company core data sheet Conducts proactive signal detection and evaluation of issues potentially related to product defects or manufacturing issues; drives the escalation and resolution of issues and product complaints In consultation with the product physician and Clinical Development representatives, prepares the Development Core Safety Information (DCSI) for assigned development products; co-ordinates and chairs meetings and tracks timelines to ensure completion
Regulatory Reports and Submissions
Drives production of periodic regulatory documents (PSURs, DSURs) according to the agreed process and timelines. Advises on strategy for the content of high profile PSURs Supports 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 Leads the SERM safety component of global regulatory submissions for new products, formulations or indications, with liaison with other functional experts
Other SERM Activities
Drives the review or production of the SERM component of Safety Data Exchange Agreements and escalates any deficiencies to the SERM Head to ensure quality and integrity of agreement. Advises on the preparation of licensing agreements in therapeutic area of responsibility Participates in due diligence activities by providing expert safety assessments and recommendations Participates in GSK internal or external meetings with project focus, including those with consultants, other companies such as licensing partners and regulatory authorities Provides support to GSK Legal for product liability litigation, as appropriate Accountable for maintaining personal readiness in response to internal audit or regulatory inspection Leads a process improvement initiative within GCSP. Contributes to advancement of methodology and process by generating new ideas and proposals for implementation Raises 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 Trains, coaches and mentors scientists in the scientific aspects of signal evaluation methodology and risk management and preparation of safety reports and other documents
EDUCATION, KNOWLEDGE AND TECHNICAL EXPERIENCE
Degree in Biomedical or Health Care related speciality
Expert evaluation skills and analytical thinking
Outstanding medical writing skills
Sound computing skills
Expert 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
Sound knowledge of the therapeutic area of assigned GSK products
Sound knowledge of other related disciplines, e.g. statistics, epidemiology relevant to assessing drug utilization and safety at the population level
In depth knowledge of medical and drug terminology and a sound foundation in pharmacology
Clear understanding of clinical development process
Clear understanding of drug approval process in major countries
Preference is someone with early phase development experience
Demonstrated track record of quality decision making and problem resolution based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context
Excellent leadership skills in the matrix team setting. Proven ability to train, coach and mentor
Ability to manage and co-ordinate tasks, projects and processes across a large organisation
Highly effective communication skills; able to present complex data to groups at all levels of the organisation and externally to GSK
Highly developed negotiating and influencing skills
Demonstrated ability to prioritise multiple tasks and deliver to deadline with high standard of quality
Contributes innovative ideas to address new issues or improve approaches to existing operations
Ability to adjust behaviours and priorities based on changing environment
Demonstrated ability to think tactically and strategically and take account of internal/external environment when considering safety issues and business processes
Ability to engage in, and contribute to, broad GSK environment with confidence, impact, integrity and professionalism
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