Safety Physician, Medical Director

Site Name: Warsaw, Mississauga, Saint Laurent Montreal, Stevenage
Posted Date: Mar 1 2023
Position summary
Who We Are: The Oncology, Immunology, and Early Phase Safety Evaluation and Risk Management (SERM) Group Global
Clinical Safety & Pharmacovigilance (GCSP) 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.
There are also opportunities to work exclusively with treatments that are in the early phases of development. 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.
Additionally, GSK is leveraging its expertise in Immunology to bring forward therapies to treat COVID-19. 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 SERM Medical Director, you will provide high level medical expertise in the safety evaluation and risk management of critical therapies in early development, submission stage and post-marketing.
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, including periodic safety update reports (PSURs). The role will be 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.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Key Responsibilities in Detail
Safety Governance and Risk Management activities

• 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
• Delivers the clinical safety input into clinical development planning activities
• Presents safety information at clinical investigator and commercial meetings
• GCSP 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
• Leads safety input into regulatory benefit risk assessments, prepares the regional Risk Management Plans for designated products for submission to regulatory authorities
• Leads thinking in GCSP 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 Benefit-Risk Management Plans
• May lead or participate in discussion at Global Safety Board or safety related findings in clinical development.
• Reviews and provides technical approval for investigator brochures, protocols, Informed consents, final study reports and external data monitoring committee charters. Ensures prompt notification to TA Head of reviewed protocols that are identified as potential PASS
• Provides medical expertise for risk evaluation and risk management planning

Signal Detection, Evaluation and Labelling

• 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
• 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
• 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
• Provides medical expertise to signal detection and subsequent evaluation for designated products in partnership with the responsible safety scientist
• 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
• 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
• 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, including On-Line Signal Management Tool, literature review and tools f or individual case awareness. Makes recommendations to SERM Head for the assessment and prioritisation of safety signals within therapeutic area

Regulatory Reports and Submissions

• Drives production of periodic regulatory documents (PSURs, Annual Reports) according to the agreed process and timelines. Acts as technical consultant on PSURs for key assets, overseeing strategy. May review PSURs, as delegated by SERM Head.
• Leads the SERM safety component of global regulatory submissions for new products, formulations or indications, with liaison with other functional experts
• 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
• Accountable for medical input, review and sign-off of periodic reports (e.g. PSURs) and renewal documentation submitted to regulatory agencies

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
• May participate in, or leads, cross-GSK activities such as safety advisory panels, task forces or scientific forums–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
• May provide medical safety support for the US and RoW Case Management functions. Reviews and approves safety reports to investigators in partnership with the Clinical Development physician
• Provides support to GSK Legal for product liability litigation, as appropriate
• Leads a complex process improvement initiative within GCSP. Participates in a broader, cross-functional process team within GSK
• 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 provide input to, or participate in, meetings of an independent data monitoring committee (IDMC) or GSK internal safety review committee (iSRC)
• 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
• May deputise for the SERM Head. May additionally deputise for the SERM Head in the Medicines Development matrix on medical issues.
• Participates in due diligence activities by providing expert safety assessments and recommendations

Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:

• Medical Degree, specialisation preferred (GMC registered or equivalent)
• In depth understanding of drug approval process in major countries–Outstanding medical writing skills–Sound computing skills
• In depth knowledge of medical and drug terminology and a sound foundation in pharmacology.
• Expert evaluation skills and analytical thinking
• Good medical judgement and ability to make medical decisions–In depth knowledge of clinical development process
• In depth knowledge of other related disciplines, e.g. statistics, epidemiology relevant to assessing drug utilisation and safety at the population level
• Industry experience –especially multi-function experience e.g. clinical safety + medical affairs/clinical development and experience in product submission activities
• 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

Behavioural Competencies

• Demonstrated ability to prioritise multiple tasks and deliver to deadline with high standard of quality
• Ability to manage and co-ordinate tasks, projects and processes across a large organisation
• Contributes innovative ideas to address new issues or improve approaches to existing operations
• Ability to engage in, and contribute to, broad GSK environment with confidence, impact, integrity and professionalism
• 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
• Excellent leadership skills in the matrix team setting. Proven ability to train, coach and mentor
• 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 f or non-physicians
• 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
• 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

Core Competencies

• 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.
• 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.
• Leadership capability – demonstrated ability to lead and inspire teams and develop and mentor individuals and allocate resource strategically and according to the portfolio priorities.
• 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.

GSK Values
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
This position may be based in Poland, Canada, UK or Netherlands depending on the candidate home location.
We’re moving towards a more sustainable future with our new headquarters. With better public transport links and proximity to world-class science and technology institutions, we’re excited for our move to the vicinity of Earnshaw Street, London WC1A (“the New HQ”).by end H1 2024.
Why GSK?
We’re uniting science, technology and talent to make a difference in more people’s lives, and revolutionising the way we do R&D.
We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.
No single scientist, nor any one technology can keep us all ahead of disease. That’s why we build important collaborations with commercial and academic partners to advance our understanding of disease and what it takes to get ahead. In the past three years, we’ve doubled the number of partnerships we’ve signed, because of our belief in their significant impact on our process.
Our pipeline currently comprises of more than 60 vaccines and medicines across four core therapeutic areas including infectious diseases, HIV, oncology and immunology as well at pursuing other science-led opportunities outside our core areas. Many have the potential to be first or best-in-class opportunities for patients and since 2017, we’ve delivered 13 major approvals and more than doubled the number of potential new vaccines and medicines in Phase 3 and registration to 23.
In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.
We give our scientists the freedom to own the process. Our scientists often use genetic data to help us understand the root cause of disease. We steer the research where the data shows we can do the most good. If a project doesn’t pan out, we take what we’ve learned and apply it elsewhere.
Find out more:
Our approach to R&D.
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 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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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