Safety Scientist, Open to flexible working
5 days left
- Contract Type
We are seeking a highly motivated individual to join GSK as a Safety Evaluation and Risk Management Specialist - called a Safety Scientist - within the Central Safety Department. This is a fantastic opportunity to utilise your pharmacovigilance knowledge and experience, as well as further develop your expertise, within a world leading pharmaceutical company.
This role with GSK is aligned to provide safety support and expertise to ViiV Healthcare, which specialises in HIV treatment, prevention and care.
The key focus of our Safety Scientist role is on safety, evaluation and risk-management.
Day-to-day you will be responsible for monitoring and evaluating safety profiles for allocated products to ensure that optimal decisions are made at all stages of the product lifecycle, which will span early clinical development, but primarily post-marketing. Depending on the individual product responsibility, the role will include conducting routine pharmacovigilance activities, signal detection/evaluation and authoring of key regulatory documents (e.g. DSURs, EU RMPs and PBRERs). Throughout delivery of the role, you will ensure that all safety documentation is accurate and available to meet global compliance and regulatory requirements.
At a more strategic-level you will be expected to drive discussions, and the management of safety issues within the wider safety team and liaise with members from other departments within GSK and ViiV's global organisations. This element of the role includes presenting safety-related findings to senior stakeholders (including Vice President and Senior Leadership Teams) and to ViiV's governance bodies.
LOCATION - Please note: This role is based at GSK House - Brentford, however, we are open to applications from individuals further afield, yet sill from a commutable distance, as we have flexibility on this role.
This role is a newly created high-profile within the Central Safety Department (as well as the wider ViiV R&D division), offering the right individual the opportunity to act as a lead or owner for the teams post-marketing activities so strong knowledge and experience of post-marketing activities is essential for this role.
You will also have a relevant degree (eg; Biomedical, Pharmacy or other Life Sciences). You will be highly self-motivated with a demonstrable passion for pharmacovigilance. You will also be resilient and calm under pressure, with strong interpersonal skills, and a continuous improvement mindset. You will have experience of working across a complex matrix organisation as you will be expected to frequently collaborate with safety staff and other groups outside of safety, including leaders throughout ViiV's R&D division.
When applying for this role please can you draw attention to the relevant Safety Evaluation and Risk Management and Post-Marketing experience that you have (in either your CV or in a covering letter). The information that you provide will be used to assess your application. Please take a copy of the job description as this will not be available after the closing date.
GSK is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands, employing over 100,000 people globally. Our products are used by millions of people around the world, helping them to do more, feel better and live longer.
- Strong pharmacovigilance experience relating to Safety Evaluation and Risk Management particularly in the post marketing environment.
- Experience in documentation writing/authoring
- Relevant Degree qualification
- Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
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