Who We Are: The Oncology, Immunology, and Early Phase Safety Evaluation and Risk Management (SERM) GroupPharma Safety
is responsible for the collection, processing and regulatory reporting of adverse events experienced by patients receiving GSK products and for the ongoing safety evaluation and risk management of all GSK products (marketed or developmental).We are seeking talented and intellectually curious individuals who wish to join us and contribute to the development and support of novel therapies in the therapeutic areas of Oncology and Immunology.
GSK is not developing a pipeline of “me too” drugs, rather we are seeking to be leaders in Oncology in the areas of immuno-oncology, synthetic lethality, epigenetics, and cellular & gene therapy. Our portfolio ranges from first-in-human compounds to marketed drugs, so there is the opportunity to learn and contribute across life cycle management. These are exciting positions because of the patients who motivate and the science which amazes us!Who You Are: Are you a safety/pharmacovigilance physician with in-depth and hands-on experience?
As the Medical Director SERM
, you will provide high level medical expertise in the safety evaluation and risk management of critical therapies in development and post-marketing, and the submission stage where the opportunity arises. 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.
You will have a proven ability to lead safety evaluation activities, ensuring that appropriate safety objectives and risk minimisation strategies are included in clinical development programmes. You will influence at all levels of the organisation using your experience, confidence and credibility, and represent the disease area or product area safety strategy at key internal GSK meetings and externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners. Additionally, you will be accountable for medical review and sign-off for regulatory documents.
This role requires an experienced safety physician with proven matrix team leadership and strong communication skills.
GSK considers the clinical safety of its products to be of paramount importance.Key ResponsibilitiesSafety Governance and Risk Management activities
Signal Detection, Evaluation and Labelling
- Delivers the clinical safety input into clinical development planning activities
- Reviews and provides technical approval for investigator brochures, protocols, Informed consents, clinical study reports and external data monitoring committee charters. Ensures prompt notification to TA Head of reviewed protocols that are identified as potential PASS
- May lead or participate in discussion at Global Safety Board for safety related findings in clinical development
- SERM representative 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 Safety Review Teams (SRTs) or co-ordinates leadership of multiple SRTs for projects in development and provides expert review of data and management of safety issues. Escalates safety issues identified through the Safety Review Process to Global Safety Board if necessary, via the TA Head. Accountable for ensuring that risk reduction strategies are included in relevant documents such as clinical study protocols and/or product labelling, as appropriate
- Provides medical expertise for risk evaluation and risk management planning
- Leads thinking in Pharma Safety around risk management plans and their implementation. For designated products, drives Pharmacovigilance and Risk Management Planning in the clinical matrix and leads production of Global Risk Management Plans
- Leads safety input into regulatory benefit risk assessments, prepares the regional Risk Management Plans for designated products for submission to regulatory authorities
- Presents safety information at clinical investigator and commercial meetings.
Regulatory Reports and Submissions
- May have overall responsibility for the signal detection and evaluation process of certain products within the SERM team, as delegated by the SERM Head. Drives signal detection for assigned products using available methodologies. Makes recommendations to SERM Head for the assessment and prioritisation of safety signals within therapeutic area
- Provides medical expertise to signal detection and subsequent evaluation for designated products in partnership with the responsible safety scientist
- Proactively leads the assessment of safety data and discusses the results with the SERM Head/ product scientist. Effectively communicates with Clinical Development and other key stakeholders on signal evaluation and labelling recommendations
- Leads presentations on labelling recommendations at Global Labelling Committee or Global Safety Board
- Produces regulatory supporting documentation for labelling updates
- Provides medical sign-off for regulatory documentation and represents GCSP as the medical member of labelling discussions
- 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 scientist 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
Other SERM Activities
- Drives production of periodic regulatory documents according to the agreed process and timelines. Supports the Local Operating Companies by preparing license renewal documentation as required for each market
- Accountable for medical input, review and sign-off of periodic reports and renewal documentation submitted to regulatory agencies
- Leads the SERM safety component of global regulatory submissions for new products, formulations or indications, with liaison with other functional experts
Candidate ProfileExperience and QualificationsBasic Qualifications
- 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 complex process improvement initiative within Pharma Safety. Participates in a broader, cross-functional process team within GSK
- May participate in, or leads, cross-GSK activities such as safety advisory panels, task forces or scientific forums
- Raises concerns/ issues 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 medical/scientific aspects of signal evaluation methodology and risk management and preparation of safety reports and other documents
- May deputise for the SERM Head. May additionally deputise for the SERM Head in the Medicines Development matrix on medical issues
- May provide medical safety support for the case processing functions. Reviews and approves safety reports to investigators in partnership with the Clinical Development physician
- May provide input to, or participate in, meetings of an independent data monitoring committee (IDMC) or GSK internal safety review committee (iSRC)
We are looking for professionals with these required skills to achieve our goals:
- Medical Doctor with specialisation preferred - Board Certified/Eligible in the US, GMC registered in the UK, or equivalent
- Industry experience - especially multi-function experience e.g. clinical safety + medical affairs/clinical development
- 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. Likely to be recognised as an authority in this area at high levels within GSK outside of GCSP and possibly in the external international pharmacovigilance arena
- Expert evaluation skills and analytical thinking
- In depth knowledge of other related disciplines, e.g. statistics, epidemiology relevant to assessing drug utilisation and safety at the population level
- In depth knowledge of medical and drug terminology and a sound foundation in pharmacology
- Good medical judgement and ability to make medical decisions
- In depth knowledge of clinical development process
- In depth understanding of drug approval process in major countries
- Outstanding medical writing skills
- Sound 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. Makes medical information/concepts accessible for non-physicians
- Highly developed negotiating and influencing skills. Ability to influence others to make sound decisions from a medical point of view by providing clear medical information
- 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
- Leadership capability - demonstrated ability to lead and inspire teams and develop and mentor individuals and allocate resource strategically and according to the portfolio priorities
- Strategic Thinking - maintains competitive advantage by carefully considering the issues and competing priorities within a situation, program or portfolio and then developing a strategy that includes the strategic application of available principles, tools and systems
- Business Acumen - Understands the implications of decisions related to human, financial, material and information resources, from a business perspective and uses this knowledge to plan, implement and manage clinical research within R&D
- Project Management - Demonstrates the discipline of risk-based planning, organising and managing resources to bring about the successful completion of specific project goals and objectives in accordance with defined quality and time-based metrics
Uniting science, technology, and talent to get ahead of disease together
GSK is a global biopharma company with a special purpose - to unite science, technology, and talent to get ahead of disease together
- so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive.
Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our R&D focus is to deliver a new generation of vaccines and medicines using thescience of the immune system, human genetics and advanced technologiesto get ahead of infectious diseases, HIV, cancer and other immune-mediated and respiratory diseases.We do all this with a commitment to operate responsibly for all our stakeholders by prioritisingInnovation, Performance and Trust.
Our bold ambitions for patients are reflected in new commitments to growth and a significant step-change in delivery over the next five years. This means more GSK vaccines and medicines, including innovative new products, will reach more people who need them than ever before.
We have long believed that building trust is key to stronger performance, helping to create value for shareholders, impact for patients and society and a reason outstanding people choose to work for and with us. That's why being a responsible business is an integral part of our strategy. Taking action on environmental, social and governance issues is a key driver in our strategy.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued and included. Where they can keep growing and look after their wellbeing.So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
Find out more: Annual Report 2021
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