CS Science Sr Scientist

Job Description Site Name: India - Andra Pradesh - Hyderabad Posted Date: Apr 1 2022 Consumer Healthcare has a large portfolio of products including medicines, cosmetics, medical devices and dietary supplements. In line with a risk-proportionate framework for product vigilance, the Consumer Safety (CS) Sr Scientist is accountable for the continued safety monitoring and safety evaluation of assigned products in clinical development and/or post-marketing setting. The position holder will: Ensure 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. Perform signal detection activities to identify, assess and escalate signals appropriately, for designated products. Provide product safety input on cross-functional teams. Support central labelling team in maintenance of product information for assigned products. Mentor / coach safety scientists. Key Responsibilities: Perform signal detection for assigned products using available methodologies (e.g. signal management tool, literature review, individual case awareness tool), with some level of support from more senior personnel, as necessary. Use appropriate sources of information and database searches to retrieve relevant data for exploration / evaluation of safety signals. Communicate, escalate and document outcomes of signal detection process. Produce accurate and fit-for-purpose evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data with some level of support from more senior personnel, as necessary. Author the safety contribution to regulatory submissions for new products, formulations or indications, or in support to license renewals Provide safety input into development programs involving all product types, including clinical studies, real-word evidence, post-authorisation safety studies, pharmaco-epidemiological studies, sensory studies and associated documentation. Assist in implementation of risk minimisation strategies in relevant documents such as umbrella branding assessments and product labelling Produce regulatory supporting documentation for labelling updates and present labelling recommendations at relevant forums. Assist in production of safety component of Safety Data Exchange Agreements. Accountable for maintaining personal readiness in response to internal audit or regulatory inspection. May represent Consumer Safety Science on cross-functional project teams and contribute to process improvement initiative within Consumer Safety. Mentor and train safety scientists on own area of expertise in relation to product safety. Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.