SERM Medical Director

Site Name: UK - London - Brentford

Posted Date: Mar 1 2023

Position summary

Who We Are: The ViiV Phase Safety Evaluation and Risk Management (SERM) Group Global

Global 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). As part of Global Safety, the work of SERM is focused on the benefit-risk strategy throughout the lifecycle of an asset, the review and analysis of safety data, safety signal detection as well as safety risk management.

This role within GSK is specifically aligned to provide safety support and expertise to ViiV Healthcare (ViiV: ) which specialises in HIV treatment, prevention and care.

Who You Are: Are you a passionate, patient-centric Safety Physician Leader, driven to deliver life-changing treatment options to patients across the globe?

We are seeking a talented and intellectually curious individual who wishes to join us in SERM and contribute to the advanced benefit-risk management of the ViiV portfolio.

In this role, you will lead a team of scientists and physicians who provide high level pharmacovigilance expertise to new and cutting-edge medicines in clinical development with a focus on early-stage development. You will ensure that adverse event and other safety information is efficiently evaluated in order to meet global compliance and regulatory requirements.

You will be a highly capable and credible leader, possessing line management experience likely gained from a safety or clinical development setting. You will have a demonstrable expertise in the safety aspects of early phases of clinical development and have a proven ability to lead safety evaluation and risk management activities, ensuring that appropriate safety objectives and risk minimisation strategies are included in clinical development programme. 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 ViiV meetings and externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners, as needed.

GSK and ViiV considers the patient safety of its products to be of paramount importance.

Key Responsibilities in Detail

Leadership

• Line management of the ViiV SERM Early Development Team, approximately 7 in number
• Support, inspire and motivate the team
• Act as the point of interface with ViiV stakeholders. e.g. clinical development for above-asset issues in the early development space
• Contribute and input to the leadership and development of the wider ViiV SERM group
• Resource planning and management
• When required, may assume safety responsibilities for an asset in the group

Safety Governance and Risk Management activities

• Delivers the clinical safety input into clinical development planning activities
• 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
• Responsible for leading a team of physicians and scientists responsible for the safety, evaluation and risk management of the early-mid development portfolio at ViiV.
• 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 ViiV Safety and Labelling Committee (VSLC) 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
• Provides medical expertise for risk evaluation and risk management planning
• Leads thinking in SERM 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
• 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

Signal Detection, Evaluation and Labelling

• 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 for individual case awareness. 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 VSLC-Produces regulatory supporting documentation for labelling updates
• Provides medical sign-off for regulatory documentation and represents SERM 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

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.
• 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
• 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 complex process improvement initiative within GCSP. 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 (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 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 US and RoW Case Management 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)

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Medical degree
• Experience in Medical Affairs including launch/peri-launch requirements
• Industry experience -especially multi-function experience e.g. clinical safety + medical affairs/clinical development and experience in product submission activities
• Understanding pharmacovigilance regulations and methodologies applicable to SERM activities
• Experience 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
• Experience of direct and cross-functional management of Safety Physicians and Safety Scientists
• Understanding of drug approval process in major countries

Preferred Qualifications

• Expert knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities
• 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, especially the early phases.
• Outstanding medical writing skills-Sound computing skills

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.

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 neurodiversity, 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).

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