Principle CMG Scientist - Drug Safety

Job description

Your Responsibilities :
A new key role has been created within our Drug Safety group. This position is responsible for ensuring that both global and local regulatory reporting requirements for spontaneous, post-marketing surveillance, and clinical trial adverse event data are met.

This role supports vendor management activities, quality oversight and risk management activities (e.g. through in-process checks), training of staff in case handling, and operational activities. This role is also responsible for inputting into process improvement initiatives that impact SMG. This role liaises with Safety Evaluation and Risk Management (SERM), Clinical Operations, Regulatory, Compliance, local operating companies (LOCs), vendors, and licensing partners across all business units.

Key Responsibilities include, but are not limited to:
• Engaging with Clinical teams on safety data collection aspects of clinical trials to include advice on study setup, configuration of Argus (central safety database) and provide subject matter expert (SME) support for Inform and other clinical process-related activities
• Supporting of periodic safety reports to investigators (PSRIs), end-of-study unblinding (EOSU)/reconciliation tools, eDX, and pregnancy registries
• Engaging with strategic partners (e.g. PPD/PXL) in outsourced clinical studies
• Interface with LOCs/IQVIA to provide oversight of local adverse event collection processes and reports for local management monitoring activities
• Supporting for data collection from Market Research (MR), Patient Support Programs (PSP), and Interactive Digital Media (IDM) activities (excluding MR/PSP reconciliation)
• Maintenance of safety contractual wording for Investigator Sponsored Studies (ISS) and MR/PSP/IDM; maintenance of adverse event reporting/reconciliation forms
• Maintenance of team site resources and content of CMG web pages
• Supporting for implementation of new regulations and maintenance of EMA/CRO/licensing partner reporting rules
• Supporting process improvement projects for processes/systems, including upgrades to the Safety database
• Supporting for Argus-related queries and trouble-shooting

CLOSING DATE for applications: Wednesday 15th May (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the ‘cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
*LI-GSK

Why You?

Basic qualifications:
• Degree in life sciences or medically-related field. Health care professional (e.g. pharmacist or nurse) preferred.
• Knowledge of spontaneous, post-marketing surveillance, and clinical trial adverse event reporting processes
• A general understanding of worldwide regulatory requirements
• Preferred experience working in a quality framework setting

Preferred qualifications:
• Vendor management experience is a plus
• Understanding of medical and drug terminology
• Knowledge of GSK products
• Knowledge of GSK safety database preferred
• Previous experience working in a complex, multicultural, matrix environment
• Experience developing and delivering high-quality training.

Why GSK? :
GlaxoSmithKline is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. We discover, make and market life-enhancing products that are used by millions of people around the world, helping them to do more, feel better and live longer. We have 3 primary areas of business in pharmaceuticals, vaccines and consumer healthcare. We have offices in more than 115 countries, major research centers in the UK, USA, Spain, Belgium and China and an extensive manufacturing network with 87 sites globally. Our three strategic priorities are to grow a diversified global business, deliver products of value, and to simplify our operating model.

Contact information:
You may apply for this position online by selecting the Apply now button.

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.

jobDetails