Safety Scientist, Senior Director (SERM)
Site Name: USA - Pennsylvania - Philadelphia Posted Date: Nov 12 2021 This role is available for US Home-Working; however the role is aligned to Eastern Standard Time so please be sure this is something you can manage appropriately if based elsewhere. This senior role will be hands on in Safety Evaluation and Risk Management (SERM) activities relating to high-profile oncology products, including defining and delivering product safety strategy, providing safety input to various cross-functional partners, and ensuring critical safety related documentation is prepared. However, you will also play a leadership role in the SERM team - heading up matrix teams, contributing to broader group decisions and strategy, acting as an exemplar of what good looks like in safety. You will be a key partner to other teams including clinical development and regulatory, working on bigger picture improvements and engagement alongside your more granular and product aligned SERM activities. This role focused primarily on upcoming and early phase oncology products, meaning you are working at the cutting edge of GSK's oncology business. As a result, this is a fast paced, highly skilled environment in which your colleagues and your partners are all experts in their own right. You'll fit into this collaborative group and contribute to the bigger picture goal of making the lives of cancer patients better. This position offers significant exposure to regulatory bodies, as well as the chance to develop critical safety strategies which help products get to market quickly but safety. Key Responsibilities include, but are not limited to: Playing a leadership role in SERM - including due diligence, audit readiness, process improvement and more Leading and contributing to Safety Governance and Risk Management activities in Oncology, driving PV and Risk Management Planning Providing clinical safety input into clinical development activities, reviewing and providing technical approval for brochures, protocols, study reports and more Representing safety on cross functional matrix and project teams, leading the management of urgent or important product safety issues Owning signal detection and evaluation process for high-profile Oncology products, driving detection using a range of tools and making recommendations based on the results and complementary safety data Consulting with the relevant cross functional team members to prepare Development Core Safety Information Driving, reviewing, and contributing to, the production of periodic regulatory documentation including PSUR's and DSUR's Representing safety at regulatory meetings and providing safety input to regulatory queries and documents. About You: SERM are part of the much wider GSK matrix, meaning the successful candidate will need highly effective communication, relationship building, influencing and negotiation skills. You must be able to present complex information appropriately for your varied target audiences, and then use this to manage expectations and provide expertise. You will need to be a leader, able to coach, train and mentor, as well as setting and co-ordinating tasks as part of critical projects. We need someone in this role who is a innovative, able to contribute ideas and solutions, challenge existing ways of working, drive change and to apply critical thinking and behavioural flexibility to problem solving - allowing you to take account of a situation or a risk and to deliver an effective and efficient solution. Last, but not least, you'll contribute to the broader GSK and Pharmacovigilance environment, so it is essential you have the confidence, impact and integrity to represent SERM, and GSK, on a global scale. CLOSING DATE for applications: Sunday 28th November (COB) Please take a copy of the Job Description, as this will not be available post closure of the advert. Why You? Required Qualifications and experience: Degree qualified in Biomedical or Health Care related speciality Experience in safety evaluation Experience of relevant pharmacovigilance regulations and methodologies applicable to Safety Evaluation and Risk Management activities Experience in causality assessment, evaluation of safety signals and proactive risk management strategies including management of labelling changes, physician and patient education. Experience in scientific writing Experience manipulating and analysing data for the detection of safety signals Preferred Qualifications and experience: Experience in Oncology Experience in other related disciplines related to assessing drug utilization and safety at a population level - such as statistics and epidemiology Experience in Pharmacology Experience of the clinical development process Experience of the drug approval process in multiple regions (EU, US, APAC etc.) Why GSK? GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer. This special purpose - along with our goal of being one of the world's most innovative, best performing and trusted healthcare companies - helps us attract some of the best and brightest minds in the world. 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