TERM Principal Scientist is responsible for safety evaluations and risk management of GSK products in relation to product quality defects. Provides scientific expertise to ensure that adverse events and other safety information are efficiently evaluated in order to assess the benefit/risk profile of the products under quality investigation. Provides safety input into the processes to improve the assessment of safety data in the course of quality investigation. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Uses appropriate internal and external sources of information to retrieve relevant (safety) data to perform Safety Medical Assessments in the context of quality issues. Collaborates with other key stakeholders (including but not limited to SERM/Medical Affairs/Toxicology/ Quality/Industrial Operations/Supply/Technical R&D functions), as appropriate, in the context of safety-quality issues. Provide strategy and/or develop responses to health authority inquiries related to product quality/safety issues. Regularly interacts with key stakeholders to maintain the network and discuss related ways of working. Trains other functions in the scientific aspects of benefit risk evaluation and preparation of safety/medical assessments and other documents. Participates in a process improvement initiative. Contributes to advancement of methodology and process by generating new ideas and proposals for implementation. Maintains personal readiness for internal audit and regulatory inspection (GVP, GMP). Provides ad-hoc support for other activities in the Transversal Evaluations and Risks Management group. Why you?Qualifications: We are looking for professionals with these required skills to achieve our goals: A university degree in Health Sciences or related disciplines (Pharmacy, Biology, Medicine, Biotechnology). Fluent English. Sound computing skills. Competent medical/scientific writing skills. Basic understanding of therapy areas of supported products. Basic knowledge of some other relevant disciplines (e.g., statistics, pharmacoepidemiology). Basic knowledge of medical and drug terminology. Experience in scientific literature review, data gathering, data synthesis, analysis and interpretation. Knowledge of relevant pharmacovigilance regulations and methodologies. Knowledge of regulations pertaining to Good Vigilance Practices and Good Manufacturing Practices. Basic knowledge of post-marketing regulations applicable to drugs. Knowledge of the principles of causality assessment and the evaluation of safety signals. Ability to use a range of sources and methods to gather information to analyze and interpret data (analytical skills). Identifies and proposes potential solutions for addressing issues/problems (problem-solving) and makes decisions with consultation. Builds effective working relationships and responds to needs of stakeholders in relation to product quality safety issues. Demonstrated effectiveness in oral and written communication. Able to effectively express ideas and incorporate feedback into deliverables to create quality output. Able to meet multiple deadlines successfully with attention to detail and quality. Able to prioritize own workload with minimal guidance. Able to contribute to the matrix environment with confidence, impact, integrity and professionalism. Able to deal with ambiguity and stays focused under pressure. Why GSK?At GSK we offer a wide range of additional benefits: Career at one of the leading global healthcare companies. Hybrid work (2/3 days per week from the office). Contract of employment. Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit). Life insurance and pension plan. Private medical package with additional preventive healthcare services for employees and their eligible dependents. Sports cards (Multisport). Possibilities of development within the role and company’s structure. Personalized learning approach (internal trainings, mentoring, access to online training platforms). Extensive support of work-life balance (flexible working solutions, short Fridays option, health & well-being activities). Supportive community and integration events. Modern office with creative rooms, fresh fruits every day. Inclusion and diversity at GSK are key for our success. Here, you will thrive through bringing your unique experiences to both our company and the recruitment process. GSK is an Equal Opportunity and Affirmative Action Employer. Applicants will travel through a transparent recruitment journey that adheres to all required employment standards and regulations. We want to hear from you and support with any adjustments that you may require during the recruitment process. 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.
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Reklama:
Term Principal Scientist
320,000 zł
Term Principal Scientist
Poland, Lubelskie, Warszawa,
Zmodyfikowano October 26, 2024
Opis
Szczegóły pracy:
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Skontaktuj się z pracodawcą
320,000 zł / W ciągu roku
Informacje o pracodawcy
We are a science-led global healthcare company that researches and develops a broad range of innovative products in three primary areas of pharmaceuticals, vaccines and consumer healthcare.
As one of the few healthcare companies researching both medicines and vaccines for the World Health Organization’s three priority diseases – HIV/AIDS, tuberculosis and malaria, we are very proud to have developed some of the leading global medicines in these fields.
Our product portfolio also includes a range of consumer brands, many of which are household names around the world, including Sensodyne, Aquafresh, Horlicks, Panadol and Tums.