Job Description

: Site Name: Bengaluru Luxor North Tower Posted Date: Oct 3 2022 Ready to help shape the future of healthcare? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease

: Site Name: Bengaluru Luxor North Tower Posted Date: Oct 3 2022 Ready to help shape the future of healthcare 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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Job Purpose. Work with Central Safety Department (CSD) for literature SERM review Perform Safety literature assessment activities for signal detection and aggregate reports purposes in accordance with their procedures and regulatory requirements. Responsible for the continued safety monitoring and evaluation of assigned GSK products in the post-marketing and clinical development setting. Ensures that adverse events and other safety information is efficiently evaluated and that safety reports are completed accurately and in a timely manner to meet global compliance and regulatory requirements. Key Responsibilities:- Signal Detection and Evaluation focusing on literature - Perform PV literature surveillance SERM assessment activities according to appropriate regulations and agreed processes - Ensure timely production of key deliverables including but not limited to: o Screening and reviewing literature search results (articles/abstracts/citations) for purposes of aggregate report inclusion and potential safety signal identification o Maintaining and documenting up-to-date product and therapeutic area knowledge to aid in literature review - Develop and share pharmacovigilance and literature surveillance knowledge and experience with team members - Recognizing potential issues and interacting with team members to resolve issues - Participate in quality or continuous process improvement activities related to area of responsibility as required - Mentoring and training new team members on literature review process as required - Support the scientists and provide medical expertise and input when needed - Discusses need for, and priority of safety related findings/ signal reviews with the SERM scientist/ SERM product specialist communicates, escalates and documents the outcome of signal detection process. - Analyses safety data and discusses the results with the SERM scientist/ SERM product specialist and another key stakeholders, as appropriate. - Knows where to find relevant safety information on products - Is familiar with aggregate reports (DSURs, PBRERs), Risk management activities (RMPS), labelling documents (GDS, DCSI) Knowledge/ Education / Previous Experience Required:- A. Educational Background 1. Minimum Level of Education- Medical degree Area of Specialization - Physician B. Job-Related Experience 5-7 years of relevant industry experience at least 2 years' experience in product safety Specifically: A university medical degree in Health Sciences or related disciplines. Pharmaceutical industry experience (e.g. drug safety (desired), regulatory, clinical development, medical affairs) Competent medical/ scientific writing skills. Working knowledge of key pharmacovigilance regulations and methodologies Basic knowledge of medical and drug terminology. Basic understanding of therapy areas of assigned products. Basic knowledge of some other relevant disciplines (e.g. statistics, pharmacoepidemiology). Experience in scientific literature review, data gathering, data synthesis, analysis and interpretation. Knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities. Basic knowledge of post-marketing regulations applicable to drugs. Knowledge of the principles of causality assessment and the evaluation of safety signals. Excellent English language skills - written and verbal particularly in scientific/medical terminology Ability to evaluate data and draw conclusions independently High attention to detail. Highly developed interpersonal, presentation and communication skills. Service-oriented attitude and ability to be a team player and interact effectively with all levels of personnel in an interdisciplinary and matrix environment. Computer proficiency, IT skills, the expertise and ability to work with web-based applications High level of flexibility and ability to prioritize work C. Other Job-Related Skills/Background Uses range of sources and methods to gather information, identifies and proposes potential solutions for addressing issues/ problems and makes decisions with consultation. Builds effective working relationships and responds to needs of stakeholders in relation to safety issues. Able to manage own tasks and projects with minimal supervision. Demonstrated effectiveness in oral and written communication. Able to effectively express ideas and incorporate feedback into deliverables to create quality output. Able to present merits of own point of view. Able to meet multiple deadlines successfully with attention to detail and quality. Able to prioritise own workload with minimal guidance. Demonstrates initiative in performing assigned tasks and responsibilities. Shares ideas with line manager on ways to improve processes for assigned tasks. Able and willing to adjust behaviours and priorities based on changing environment. Demonstrates confidence in own ability, integrity and professionalism in interactions with colleagues At GSK we value diversity (Gender, LGBTQ +, PwD etc.) and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution. .LI-GSK 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. 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