Head of Safety (PV) Risk Management and Benefit/Risk Evaluation

Are you interested in a critical role that will allow you to shape and execute the Pharmacovigilance Risk Management group strategy within GSK? If so, this Head of Safety Risk Management and Benefit/Risk Evaluation role could be an ideal opportunity to explore. Reporting to a Vice President, Safety Evaluation and Risk Management in Global Safety, you will be responsible for providing strategic guidance for risk management and benefit/risk evaluation activities for programs in all therapeutic areas within GSK.

Key Responsibilities:

This role will provide you the opportunity to develop and lead the Safety Risk Management and Benefit/Risk Evaluation group within GSK. Key responsibilities include, but are not limited to:

• Serving as a subject matter expert in risk management and benefit/risk evaluation within the Global Safety Department and cross-functionally within GSK
• Assessing the risk management needs among the current GSK programs and ensuring all are met at the highest level of competence and compliance
• Providing strategic input into future REMS and Risk Minimization Measures globally including their development, implementation, tracking, and assessment of effectiveness
• Assisting in the characterization of risks in development program (upon request)
• Supporting, as needed, the teams' creation/update of Risk Management Plans
• Guiding program teams through a more structured benefit/risk evaluation (upon request)
• Participating in the creation/update of processes related to Risk Management and benefit/risk evaluation
• Collaborating with the Global Safety Global Process Owners (GPOs), the Innovation & Analytics team, and other groups within the Global Safety department
• Helping with regulatory intelligence activities and promotion of best practices around risk management and benefit/risk evaluation
• Creating a strategic plan for expansion of risk management resources to meet the future needs of GSK
• Developing strong collaborative relationships with Epidemiology, Regulatory Affairs, Medical Affairs, and other key stakeholders
• Engaging with senior management within Global Safety and beyond to advocate for the Risk Management group

Basic Qualifications:

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

• MD, PharmD, PhD, or its equivalent
• Significant relevant pharmaceutical industry experience (5-8 years) in Risk Management and benefit/risk evaluation
• Must have a strong understanding of FDA, EMA and other Health Agency regulations (particularly those surrounding Risk Management activities) and drug development
• Ability to develop and execute a Risk Management strategy and its operations for a program
• Extensive knowledge and understanding of PV deliverables, standards and processes for Risk Management at a global level (e.g., creation and updates of RMPs and DRMPs; development and execution of a REMS; creation and administration of Risk Minimization Measures and assessment of their effectiveness)
• Previous experience with application of qualitative/quantitative benefit/risk methodology
• Ability to navigate across and provide strong leadership in a matrixed environment, while building collaborative, cross-functional relationships
• Excellent written and oral communication skills, with ability to influence others
• Strong scientific/medical/clinical acumen and analytical skills
• Proficient in prioritizing assignments and able to adapt to rapidly changing priorities

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Experience in other areas of Pharmacovigilance
• Prior work in the oncology therapeutic area
• People management experience
• Capacity to complete complex assignments independently
• Ability to simplify complex concepts and communicate to diverse audiences

Why GSK?

We're uniting science, technology and talent to make a difference in more people's lives, and revolutionizing 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.

Our pipeline currently comprises of more than 60vaccines 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.

Find out more:

Our approach to R&D.

#LI-GSK

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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