TERM Principal Scientist

Job title:

TERM Principal Scientist

Company:

GlaxoSmithKline

Job description

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 range of sources and methods to gather information to analyze and interpret data (analytical skills)
• Identifies and proposes potential solutions for addressing issues/ problems (problems 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 prioritise 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
• Sports cards (Multisport)
• Possibilities of development within the role and company’s structure
• Personalized learning approach (internal trainings, mentoring, access to online training’ platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
• 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

#LI-GSK#LI-HYBRID#LI-DEIInclusion 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. We want you to be you, feel good and keep growing your career.
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. Beyond this, we commit to our values of integrity and respect towards every applicant.
We want to hear from you and support with any adjustments that you may require during the recruitment process. Please get in touch with our Recruitment Team ( ) to further discuss this today.
We will request equal opportunities information from you and whilst disclosure is optional, we encourage you to be open, enabling us to monitor the inclusivity of our recruitment practices for the benefit of everyone. Your data will remain confidential, is never shared with our Hiring Managers and never affects the status of your application. *Local restrictions/legal requirements

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.GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.Important notice to Employment businesses/ AgenciesGSK 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.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting site.

Expected salary

Location

Warszawa, mazowieckie

Job date

Wed, 16 Oct 2024 00:58:15 GMT

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