Safety Scientist – SERM (Safety Evaluation and Risk Management)

As a Safety Scientist you will work with the SERM Safety Physician to actively manage and evaluate risks associated with assigned vaccine projects, and make recommendations for the management and communication of risks in accordance with global legal and regulatory frameworks. This may involve the following:

• Coordinate and perform initial analysis of adverse event reports and/or signal detection activities for assigned vaccine projects in clinical development and post-licensure.

• Be the safety contact person for Clinical, Regulatory Affairs, regional and LOC (local operating company) safety managers, manufacturing teams for assigned vaccine projects.

• Provide input to Clinical Teams with respect to safety aspects of the design and preparation of protocols, investigators brochures, investigator letters and reports, for the follow up and processing of clinical study data and lead the safety analysis of the assigned projects.

• Contribute to the creation, maintenance and implementation of (D)CSI (Development, Core Safety Information) for the assigned projects.

• Contribute to the Benefit Risk Assessment and risk identification, assessment and mitigation activities for assigned vaccine projects.

• You perform database searches to obtain information from the Safety Database.

• You assist in the review of aggregated adverse event reports for signal detection, evaluation and management purposes for assigned vaccine projects.

• You assist in drafting relevant clinical safety reports (including labelling documents, ad hoc reports and position papers) in collaboration with the safety physician.

• You assist in the review of protocols, study reports, IDMC charters, and operational activities associated with appropriate data provision and presentation of material.

• You contribute to appropriate and timely Benefit Risk Assessments for assigned vaccine projects.

• You contribute to the design, tracking and follow up of risk management plans for the products assigned and assure their sound implementation.

• You assist in the review of safety data from other databases (literature review).

• You summarize safety data effectively for use in regulatory or clinical trial documents (e.g. ad-hoc queries, PBRERs, PSURs and DSURs).

• You assist in answering and follow-up of inquiries from regulatory authorities and other bodies (e.g., Ethics Committees) regarding safety related aspects.

• You contribute to or even lead the cross-functional Safety Review Team for assigned vaccine project.

• You assist in the implementation and follow-up of safety data exchange agreements for products assigned.

• You contribute to process improvement and documentation/discussions on procedures; provide support for training to stakeholders.

Basic Qualifications:

• Degree in a biomedical or health care-related specialty

• 2-3 years clinical safety experience or equivalent experience ( e.g. clinical development in a pharmaceutical company, regulatory authority etc.)

• Basic understanding of safety evaluation methodology/ process awareness of pharmacovigilance regulations and methodologies.

• Understanding of medical terminology

• Experience in drafting responses to ad hoc queries or evaluating significant safety issues for regulatory submissions (e.g., PSURs ) under supervision.

• Good English oral and writing skills.

• Computer literate, familiar with using scientific and clinical databases.

Preferred Qualifications:

• High degree of accuracy with attention to detail.

• Detail oriented, methodical and analytical approach.

• Good communication skills, team spirit, flexibility.

• Ability to manage crisis, monitor safety issues and work under pressure with a customer and solution oriented approach.

• Able to prioritize activities effectively and to meet multiple deadlines successfully with attention to detail, setting high performance standards for quality.

• Demonstrate initiative and creativity in performing task and responsibilities. Proactively contributes ideas to improve existing operations.

• Li-GSK

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.

GSK Vaccines – Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries.

For further information, please visit www.gsk.com.

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

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

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.