Safety Evaluation and Risk Management Scientific Director
City : 7333 Mississauga Road North
Category : Other
Industry : Healthcare
Employer : GSK
Posted Date: Jan 11 2023
As a member of the SERM (Safety Evaluation and Risk Management) group at GSK, you will provide key safety leadership and expertise to the Oncology portfolio. This will span from clinical development right through to marketed products, offering a true breadth of experience in safety. Through signal detection, signal evaluation, data review and other pharmacovigilance tasks, you will ensure all safety information is efficiently evaluated in keeping with global compliance end regulatory requirements. You will identify need for updates in labelling and drive other proactive changes to enhance risk management.
The SERM team is a highly collaborative and matrixed organization, which works in partnership with the wider business. As such, the successful candidate will need excellent communication and team working skills and must be comfortable with influencing and negotiate at all levels. This will also require flexibility and adaptability, adjusting behaviors to meet the current need. You must be able to make quality decisions and resolve problems while dealing with complex information, absorbing and evaluating considerable data to do so. It’s also important that you are comfortable with multi-tasking and prioritizing, as well as dropping in and out of projects at short notice in order to best support the safety needs of the wider team. This is a group that works best as a whole, so sharing and helping one another is crucial to this success.
As a leader in safety, you’ll also need to be comfortable with training, coaching and mentoring. You’ll set a positive example, whilst also helping to delegate and coordinate tasks, projects etc. Within these projects you’ll need to be credible and effective, contributing impactful and innovative ideas which support tactical and strategic improvements with both a safety and a commercial business perspective.
We need someone who can be a real safety leader in this role. You won’t just be gathering data, but will need to interpret and understand key safety information, translating this into positive or remedial actions which drive safety objectives and risk mitigation, as well as promoting a positive and progressive safety culture – including influencing and engaging with partners in a range of functions within the business.
Due to the size of our oncology portfolio, this position will offer considerable exposure to the drug product lifecycle and a real variety of product, including immuno-oncology drugs. You will be part of a complex, matrixed organisation full of passionate, motivated and committed safety experts – individuals you can learn from, share with and support in your own right. This is a team that works in an extremely collaborative way, guaranteeing variety, flexibility and opportunity for the successful candidate.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Key Responsibilities include, but are not limited to:
- Significant contribution to safety, pharmacovigilance and risk management activities for the Oncology portfolio.
- Participation in cross functional, matrixed teams, in which you play a safety leadership role.
- Providing technical input, review and approval to a range of key documents and processes, including presenting safety information during clinical and commercial meetings.
- Drives and conducts signal detection within Oncology, subsequently leading assessment of safety data, results and potential recommendations.
- Producing accurate and appropriate documentation to support regulatory filings and other investigations.
- Playing a positive role in the production and submission of high-quality regulatory documents, including supporting LOC’s with license renewal documentation and more.
- Contributing expert safety knowledge to a range of due diligence activities, internal assessments and audits etc.
- Leading process improvement initiatives within SERM which contribute to advancements in methodology and process through new ideas, new implementations, continuous improvements and more.
- As a leader, contribution to the training, coaching and mentoring of others in signal evaluation, risk management and safety, acting as an exemplar of safety and risk management practices.
We are looking for professionals with these required skills to achieve our goals:
- PharmD, Pharmacist, Nurse, Nurse Practitioner or other formal education in Biomedical or Health Care specialism.
- 5 years’ experience in a Safety / Pharmacovigilance position.
- 10 years’ experience in Pharma industry.
- Experience in Medical writing.
- Experience analyzing safety data to drive solutions.
- Experience of pharmacology.
- Experience of the clinical development and approval process.
If you have the following characteristics, it would be a plus:
- Oncology Drug Development experience.
- Experience of marketed/commercial products in Oncology or Immunology.
- Experience in statistics and epidemiology.
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. 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-inclass 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:
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.
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