Director, SERM - Oncology (Open to flexible working)
As a Director in this role, you will provide 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.
You will ensure 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
As the Director, SERM of Oncology, you will also 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.
- Drive pharmacovigilance and risk management planning in the clinical matrix and lead production of global Benefit-Risk Management
- Plan for designated products
- Lead safety input into regulatory benefit-risk assessments, prepare the regional Risk Management
- Plan 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 and 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. 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
- 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
- Effectively 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 representatives, prepare the Development Core Safety Information (DCSI) for assigned development products; co-ordinate and chairs meetings and track timelines to ensure completion 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 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
- Lead the SERM safety component of global regulatory submissions for new products, formulations or indications, with liaison with other functional experts
Other SERM Activities
- Drive 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
- Advise on the preparation of licensing agreements in therapeutic area of responsibility
- Participate in due diligence activities by providing expert safety assessments and recommendations * 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 Leads a process improvement initiative within GCSP
- Contribute 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.
- 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.
- Degree in Biomedical or Health Care related speciality
- Expert evaluation skills and analytical thinking
- 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
Pharmacovigilance experience highly preferred
* LI 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.
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