Safety Specialist (Evaluation & Risk Management)

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. The key focus of the Safety Scientist is on safety evaluation and risk-management. You will be a GSK-employee but will be aligned to provide safety support and expertise to ViiV Healthcare (www.viivhealthcare.com), which specializes in HIV treatment, prevention and care. 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 may span early clinical development through to established post-marketing use. 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). Initially this role will include providing safety support for clinical trial activities and contributing to marketing authorization applications. 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's global organization. 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 currently based at GSK's Stockley Park location but will be moving to be based at GSK's head-office (Brentford, West London) during Q4 this year. We are also able to consider suitably experienced applicants who can be based at the GSK Stevenage site (on the understanding that they travel to Stockley Park/GSK House as needed for business meetings). About You: This role is high-profile within the Central Safety Department (as well as the wider ViiV R&D division) and so strong knowledge and experience specifically relating to Safety Evaluation and Risk Management is considered a pre-requisite for the role. Experience of clinical trial activities and marketing authorization applications would be an advantage. 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 organization, 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. CLOSING DATE for applications: Monday 15th of June 2020 (COB). When applying for this role please can you draw attention to the relevant Safety Evaluation and Risk Management experience that you have (in either your CV or in a covering letter). This should include any experience of supporting clinical trial activities and marketing authorization applications. The information that you provide will be used to assess your application. About GSK: GSK is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. Our products are used by millions of people around the world, helping them to do more, feel better and live longer. Employing over 100,000 people globally, we have 71 manufacturing sites around the world. For more information on GSK please refer to our website: www.gsk.com Basic Qualifications: * Strong pharmacovigilance experience relating to Safety Evaluation and Risk Management. * Relevant Degree qualification. * Signal Detection and Evaluation experience (clinical trial and submission experience would also be a distinct advantage). * Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes. As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way. 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 race/ethnicity, colou