Safety Scientist SERM (Safety Evaluation and Risk Management)

Job description

Details:
Be part of a new team for an exciting and growing business and world's leading vaccine organization in our new R&D Center in Rockville, Md.

We are seeking Safety Scientists to support two divisions within the GSK Rockville Vaccines group. You will have the opportunity to be on the ground floor of a new organization and site, and you will be part of a new culture of some of the best scientific minds in vaccine research. Come deliver the GSK Vaccines strategy by driving vaccine R&D projects through innovation, collaboration, cutting edge science, exceptional people, and end-to-end quality performance.

You will work with the SERM 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.

Coordinate and perform initial analyses 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 analyses 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

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 enquiries 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.

Generating reliable safety data from large and multinational study environment (200,000 subjects for the ongoing studies)
Providing scientifically based safety assessments within complex public environment..

Location: Rockville, Maryland

*LI-GSK

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

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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.

Preferred qualifications:
•High degree of accuracy
•Detail oriented, methodical and analytical approach.
•Good communication skills, team player, flexible.
•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
•Demonstrated writing skills.
•Computer literate, familiar with using scientific and clinical databases