Job title: CMG Scientist
Company: GlaxoSmithKline Pte Ltd
Job description: Job Description : Site Name: UK – London – Brentford, Belgium-Wavre, India – Karnataka – Bengaluru, UK – Hertfordshire – Stevenage Posted Date: Oct 8 2021 Principal Scientist CMG Excellence ‘Be You’ at GSK At GSK, we’re a company with a purpose to h
Job Description : Site Name: UK – London – Brentford, Belgium-Wavre, India – Karnataka – Bengaluru, UK – Hertfordshire – Stevenage Posted Date: Oct 8 2021 Principal Scientist CMG Excellence ‘Be You’ at GSK At GSK, we’re a company with a purpose to help people do more, feel better and live longer. We realise that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process. We will be delighted to hear from talented individuals that align to our values. These are at the heart of everything we do and include: Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. When you set out on your adventure at GSK, we make a deal. You commit to living our values and expectations and performing against our Innovation, Performance and Trust priorities. In return, GSK commits to providing the right environment for you to thrive. Together, we build an environment where we can all thrive and focus on what matters most to each of us. As a modern employer, we empower you to be yourself, share ideas and work collaboratively. GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. The key purpose of this role is to ensure the safety of all GSK Clinical Trial participants, patients, and consumers administered or using GSK products, by supporting the successful collection, processing and reporting of safety data of GSK products globally. This role ensures that case management activities align with GSK standards for processing human safety information (HSI) and that regulatory requirements, including timelines are achieved. This is done by driving the implementation of robust processes and training for successful performance of case management activities, including PV vendor oversight mechanisms. The job holder provides relevant CMG Excellence-related oversight to the Case Management Group (CMG) Directors and drives the understanding of case management requirements across all business units. Key Responsibilities include, but are not limited to: Core CMG Excellence Accountabilities Contributes to all aspects of processes and written standards that describe case handling activities from case receipt to expedited reporting and collaborates with stakeholders (e.g. the Safety Evaluation and Risk Management (SERM) group, local operating companies (LOCs), and Clinical Operations) to ensure that documentation and processes are in place to achieve successful recording and reporting of safety data during the life cycle of a clinical trial and marketed product. Works across a complex matrix environment to drive high-quality delivery of case management activities that comply with internal standards and external regulatory requirements Where process or training issues are identified, facilitates investigation into root cause, creation of corrective/preventative actions (CAPAs), and supports with remediation of process/training needs Reviews and maintains oversight of any CMG training materials developed Prepares internal and external presentations as required, working closely with content owners and experts within the team Implements changes to CMG training curriculums in line with current CMG structure and maintains oversight of all CMG training aspects Manages CMG Excellence mailboxes for responsible workstream and responds to allocated queries in a timely and professional manner Identifies changes to regulations that may impact CMG activities, assesses impact, coordinates implementation of changes and tracks change. Tracks and oversees regulatory enquiries sent to CMG, ensuring appropriate, thorough and timely responses Coordinates appropriate archiving, in line with GSK Global Archiving processes, ensuring the successful retrieval of documentation and supporting inspection-readiness Where problems or issues are identified, escalates to CMG Excellence Manager / Director, as appropriate Generates new ideas and proposals for global implementation contributes to advancement of CMG methodology and optimization of processes. Demonstrates GSK values during interactions Principal CMG Scientist, CMG Excellence Accountabilities Supports Scientists with enhancement of knowledge and skills with regards to CMG Excellence activities, where required Identifies training needs and works with CMG Excellence colleagues to prepare, coordinate and deliver training to staff within CMG and other stakeholder groups Acts as a Global Case Management leader for process discussions, including queries on strategy/policy-related decisions authors or provides significant input into the development of written standards Closing Date for Applications: Friday 15th October 2021 Please take a copy of the , as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process. *LI-GSK Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Degree in life sciences or medically-related field or previous experience equating to educational requirements Knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP), clinical safety documentation, reporting of adverse events from clinical trials, local regulatory requirements, and pharmacovigilance methodology general understanding of worldwide regulatory requirements Working knowledge of principles of data collection, manipulation and retrieval and experience summarizing data In-depth understanding of medical and drug terminology Proven experience of prioritisation and time management Strong communication skills In-depth knowledge and experience of safety databases Solution-driven and proactive way of working Ability to map processes and author/review written standards Preferred skills:- Project management experience Audit and inspection management experience Knowledge and experience with Argus 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. We take pride in providing access to all and continually focus on our opportunity and obligation to do more to improve inclusion and diversity: for our people inside GSK in the way we do business and in the communities where we operate. We want our company to be a place where diversity of people and thought is valued everywhere and where we’re all able to be ourselves and feel a sense of belonging. An inclusive organization where we all feel valued, engaged and supported, knowing that our work makes an important contribution to our mission. Reinforced by our clear values and expectations, it is part of our DNA. Together we achieve extraordinary things for our patients and consumers, who rely on us each and every day. 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, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only). 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Job date: Mon, 11 Oct 2021 22:26:38 GMT
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