Safety Scientist SERM (Safety Evaluation and Risk Management)

Job description

Details:

Our Company:

GSK is a science-led global healthcare company with a mission to help people do more, feel better, live longer. At GSK, we research, manufacture and make available a broad range of medicines, vaccines and consumer healthcare products.

GSK Vaccines is a world's leading company, involved in vaccine research, development and production. We have 16 candidate vaccines in development and our broad portfolio of around 40 vaccines prevent illnesses such as hepatitis A, hepatitis B, diphtheria, tetanus, whooping cough, measles, mumps, rubella, polio, typhoid, influenza and bacterial meningitis. Globally, we have more than 16.000 people working to deliver vaccines safely, every day, to people in 90% of the world's countries. In 2014 we distributed around 800 million doses of vaccine, 80% of them to least developed, low and middle income countries.
For further information, please visit www.gsk.com.

Job Purpose:

To 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.

Key Responsibilities:

• Perform database searches to obtain information from the Safety Database.
• Assist in the review of aggregated adverse event reports for signal detection, evaluation and management purposes for assigned vaccine projects.
• Assist in drafting relevant clinical safety reports (including labelling documents, ad hoc reports and position papers) in collaboration with the safety physician.
• Assist in the review of protocols, study reports, IDMC charters, and operational activities associated with appropriate data provision and presentation of material.
• Contribute to appropriate and timely Benefit Risk Assessments for assigned vaccine projects.
• Contribute to the design, tracking and follow up of risk management plans for the products assigned and assure their sound implementation.
• Assist in the review of safety data from other databases (literature review).
• Summarize safety data effectively for use in regulatory or clinical trial documents (e.g. ad-hoc queries, PBRERs, PSURs and DSURs).
• Assist in answering and follow-up of inquiries from regulatory authorities and other bodies (e.g., Ethics Committees) regarding safety-related aspects.
• Contribute to or even lead the cross-functional Safety Review Team for assigned vaccine project.
• Assist in the implementation and follow-up of safety data exchange agreements for products assigned.
• Contribute to process improvement and documentation/discussions on procedures; provide support for training to stakeholders.

Offer:

We seek candidates who can make outstanding long-term contributions to our organization and evolve to roles of increasing importance (broader business process scope, larger project size, integration with other applications, …).

The benefits of working at GSK Vaccines include innovative projects, passionate people and a truly global business atmosphere. 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.

Contact information:

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

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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.

Desired profile

Basic qualifications:

• Bachelors level or above 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.
• 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.
• Good English writing skills.
• Computer literate, familiar with using scientific and clinical databases.

Preferred qualifications:

See Basic Qualifications