Clinical Safety Scientist
6 Month Contract - Maternity Leave Cover
Remote Working, UK
Pay rate up to £599 per day via Umbrella inside IR35
Who Are We - GSK?
We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. GlaxoSmithKline plc was formed in 2000 as a result of a merger between Glaxo Wellcome plc and SmithKline Beecham plc , although our history can be traced back more than 300 years to London’s Plough Court Pharmacy in the 1700s.
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. Our strategy is to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our three global businesses, scientific and technical know-how and talented people. Our values and expectations are at the heart of everything we do and form an important part of our culture:
- Our values are Patient focus, Transparency, Respect, Integrity
- Our expectations are Courage, Accountability, Development, Teamwork
- 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
SAFETY GOVERNANCE AND RISK MANAGEMENT ACTIVITIES:
- Drives pharmacovigilance and risk management planning in the clinical matrix and leads production of global Risk Management Plans for designated products.
- Reviews and provides technical approval for investigator brochures, protocols, Informed consents, final study reports and external data monitoring committee charters.
- Leads safety input into regulatory benefit-risk assessments.
- Delivers the clinical safety input into clinical development planning activities.
- Represents Global Safety on cross functional Clinical Matrix Teams and/or Project Teams.
- Leads cross-functional ad hoc teams to address urgent and important product safety issues.
- 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.
- 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 LABELING:
- Drives signal detection for assigned products using available methodologies.
- 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 product physician.
- Effectively communicates with Clinical Development and other key stakeholders on signal evaluation and labelling recommendations.
- Produces accurate and fit for purpose evaluation documents with clear conclusions, in response to internal or regulatory authority requests for safety data.
- 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 SAFETY EVALUATION AND RISK MANAGEMENT (SERM) ACTIVITIES
- Participates in GSK internal or external meetings with project focus, including those with consultants, other companies such as licensing partners and regulatory authorities
- Accountable for maintaining personal readiness in response to internal audit or regulatory inspection
- Leads a process improvement initiative within Global Safety.
- 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 specialty
- 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
- Clear understanding of clinical development process
- Sound knowledge of other related disciplines, e.g. statistics, epidemiology relevant to assessing drug utilization and safety at the population level
- Expert evaluation skills and analytical thinking
- Strong medical writing and computing skills
- 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.
- Demonstrated ability to prioritise multiple tasks and deliver to deadline with high standard of quality
- 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.