Safety Evaluation Scientist I-Literature - Bengaluru, India - 14260 GSK India Global Services Private Limited
Description
Job Purpose:
− Work with Global Safety for literature evaluation in Safety Evaluation and Risk Management (SERM). − 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 postmarketing 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 evaluating 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 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 - Contribute 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 - Discusses need for, and priority of safety related findings/ signal reviews with the SERM product specialists / SERM physician, communicates, escalates and documents the outcome of signal detection & management process. - Analyses safety data and discusses the results with the SERM product specialists/ SERM physician and other 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) Expected competencies for this role: − Relevant experience, practical experience, consistent performance and some autonomy with some supervision required for executing the safety activities related to but not limited to scientific literature review, data generation & gathering, data analysis & interpretation and effective prioritisation of tasks − Growing ability to confidently communicate with scientific, technical or medical audiences and to tailor information appropriately. − Growing ability to showcase persuasive arguments with stakeholders in a timely manner. − Developing confidence in making challenging decisions. − Receives feedback and developing coaching awareness and begins to use the approach during personal and professional development conversations. − Listen to and be sensitive to the views and values of others. Understands and relates to others from different cultural background, including peers and stake holders in an open, friendly and professional way. − Aware of the multiple channels available for communication − Communicates effectively and provides appropriate scientific, technical, or medical input at the team level.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
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.
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