SERM PRINCIPAL SCIENTIST
Site Name: Home Worker - POL
Posted Date: Mar 7 2023
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.
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.
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SERM PRINCIPAL SCIENTIST
"Safety Evaluation and Risk Management " Principal Scientist
In this role you will…
1) be responsible for Safety Governance and Risk Management activities:
- Author global Risk Management Plans/ regional Risk Management Plans for designated products, in consultation with senior colleagues.
- Assist in establishing Safety Review Teams and provides data for review and discussion.
- Produce accurate and fit for purpose evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data.
- Routinely monitor safety issues potentially related to a product defect and/or manufacturing issue; communicate with the SERM physician/ SERM Head and/or Manufacturing
- Coordinate production of Development Core Safety Information (DCSI) for assigned products
- Run routine signal detection processes, including review of case reports
- Use appropriate sources to retrieve relevant data for evaluation of signals
- Be responsible for labelling recommendations with SERM physician
- Produce accurate evaluation documents to internal or regulatory authority requests
- Monitor safety issues potentially related to a product defect and/or manufacturing issue
- Support the Local Operating Companies by preparing license renewal documentation
- Provide safety contribution to global regulatory submissions for new products or indications
- Mentor and train more junior scientists in own areas of expertise
2) be also responsible for Regulatory Reports and other Submissions:
- Author periodic regulatory documents (PBRERs) according to the agreed process and timelines.
- Support the Local Operating Companies by preparing license renewal documentation (e.g. Addendum Reports, Line listings, Clinical Overviews), as required for each market.
- Author the SERM safety contribution to other global regulatory submissions for new products, formulations or indications or answers to safety-related questions from Regulatory Agencies, in cooperation with relevant functional experts
- A university degree in Health Sciences or related disciplines
- Fluent English
- Knowledge of relevant pharmacovigilance regulations and methodologies
- Knowledge of post-marketing regulations applicable to drugs.
- Knowledge of the principles of causality assessment and the evaluation of safety signals
- Able to manage own projects independently and coordinate activities of others
- Able to meet multiple deadlines successfully with attention to detail and quality
- Proactively share ideas with line manager on ways to improve processes
- Able to train others/ act as a subject matter expert in the designated area
- Effective oral and written communication in English
- Strong medical/ scientific writing skills.
- Career at one of the leading global healthcare companies
- Contract of employment
- Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
- Life insurance and pension plan
- Private medical package with additional preventive healthcare services for employees and their eligible counterparts
- Sports cards (Multisport)
- Possibilities of development within the role and company’s structure
- Personalized learning approach (mentoring, online training’ platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external training
- Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities)
- Supportive community and integration events
- Modern office with creative rooms, fresh fruits everyday
- Free car and bike parking, locker rooms and showers
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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