Principal Toxicologist, Senior Specialist level
- Educational background: minimum Master's in Sciences or in Pharmacy (mandatory)
- Minimum 3 years of experience in a Drug Safety, Epidemiology, Regulatory Affairs or Quality role where Toxicological evaluations are part of the activities performed (mandatory)
- Experience in the Pharma or Biotech industry (mandatory)
- Fluent in English (written and spoken)
- Specialisation in Toxicology is desired
- Fluent in French
Be familiar with:
- Regulatory requirements and standard methodologies related to GMP and GVP,
- GMP regulations,
- Vaccine manufacturing and manufacturing QA,
- PV practices, including case processing, aggregate reporting, signal detection and management.
The successful candidate demonstrates strong ability to:
- Think critically and innovatively, identify and solve problems,
- Communicate, influence and persuade effectively,
- Interact well in a multi-functional team and complex environment,
- Commit to continuous improvement.
- The function is part of the Patient Safety and Manufacturing Liaison group within Vaccines Clinical Safety and Pharmacovigilance. The Pharmacovigilance Toxicologist conducts toxicological investigations to support Quality Assurance in Manufacturing and Clinical Safety and Pharmacovigilance. The Toxicological risk assessment is a critical element in the management of quality systems it affects products to be released and products already on the market. This is directly related to the Company's commitment for patient safety and product quality.
- Performing toxicological evaluations and delivering toxicological analyses reports
- Participation in representing Vaccine Clinical Safety and Pharmacovigilance in Manufacturing and Quality meetings (e.g. product incident reviews, Global Quality Councils, interaction meetings)
- Acting as a point-of-contact between Vaccine Clinical Safety and Pharmacovigilance and Manufacturing Operations and Global Quality for all toxicological support.
- Delivery of toxicological Support and expertise for Manufacturing Quality
- Representing at GMP and GVP inspection and being a subject matter expert for all toxicological investigations reviewed in the context of CMP/GVP inspections.
- Conducting literature searches for nonclinical toxicology and safety information.
- Maintaining a toxicological database for residuals and contaminants.
- Following up on inquiries from Manufacturing and Quality Assurance in manufacturing (for example provision of expert toxicological advice for deviations, extractables & leachables and other manufacturing quality issues).
- Complementing the toxicological investigations by Clinical Safety and Pharmacovigilance assessments when required.
- Interacting with various groups within the Company to acquire expertise necessary to perform the job and to facilitate integrated assessments.
- Supporting the Safety and Quality Assurance interactions unit by performing qualitative and quantitative safety and pharmacovigilance evaluations.
- Providing other support to the unit in their routine and ad-hoc activities such as data management and signal detection and evaluation).
- Participating to research to improve the signal management for manufacturing related incidents.
- The job holder will ensure effective, team work among departments/functions
At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.
Patient-focused Research and Development (R&D) is the heart of our business. Our R&D department seeks to discover and develop new vaccines, to protect against diseases where vaccines are not yet available and to improve on those vaccines that already exist. Part of our R&D programme targets diseases particularly prevalent in the developing world, including the World Health Organisation's three priority diseases - HIV/AIDS, tuberculosis and malaria. Research into candidate vaccines for other diseases of the developing world, such as dengue are at an earlier stage of development.
When it comes to developing the vaccines of the future, we're looking for real experts in their respective fields who are interested in working in the stimulating environment of an international healthcare company.
We emphasise the value of teamwork and we look for people ready to share our values of transparency, respect, integrity and patient focus.
GSK is one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GSK Vaccines is one of the world's leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development. We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world's countries.
For further information, please visit www.gsk.com.
You may apply for this position online by selecting the Apply now button.
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