Job Description

“This role is currently work-from-home and will move to the office environment after the COVID-19 restrictions are lifted.”

Job Description: JOB TITLE: Safety Scientist

EDUCATION PREFERRED: : B.S.N./RN, B.A./B.S./M.S. (Life Sciences); B.S. Pharm./R.Ph./Pharm.D. or equivalent.

YEARS OF EXPERIENCE PREFERRED: 4 years experience in a clinical development setting or 2-3 years Safety experience within the pharmaceutical industry.

LIST MAJOR SKILLS REQUIRED:
• Experience writing narratives for study drug safety reports.
• Experience using a drug safety database to capture adverse events.
• Experience applying medical knowledge in a business context.
• Experience working in a post-marketing safety or clinical trial setting (i.e., CRO, pharmaceutical company and academic setting).
• Experience working in teams, including supporting other team members when necessary.
• Strong teamwork (with ability to lead a team) and prioritization skills to ensure that processes, procedures and best practices are consistent across GPV&E and that Regulatory requirements are met in a timely manner with high quality.
• Ability to make constructive recommendations to improve processes.
• Demonstrates the ability to multi-task, and flexibility to meet changing business priorities.
• Maintains an in-depth knowledge of the ARGUS Safety Database and Clinical Databases such as RAVE/Trial Access Online etc, and is able to query the systems to support the SUSAR/ESR scientist role.
• Ability to collaborate within multi-disciplinary team on drug safety-related issues including informing safety physicians and scientists within the therapeutic area on case-related issues.
• Ability to apply sound analytical thinking and database query skills to gather, review, summarize and evaluate critical information in a timely manner.
• Strong knowledge of SUSAR process, SOPs, conventions and health authority regulations worldwide, to ensure all safety information is accurate, integrated and current, and is submitted within regulatory timelines.
• Utilizes medical, scientific and clinical knowledge in reviewing safety-related documents (e.g. protocols, investigator brochures, product labels, relevant source documents) and incorporating key concepts to clearly present the reported events, and in turn, maintain patient safety.
• Possess medical writing skills to produce accurate, concise, medically sound expedited reports.

LIST RESPONSIBILITIES REQUIRED:
• Ability to support GPV&E Vision and Mission through an understanding of the impact and implications of daily work on all customers of the Expedited Safety Report Group.
• Medical and pharmaceutical knowledge (i.e., scientific understanding of the human body and its functions).
• Knowledge and understanding of Health Authority Regulations worldwide, how to access them and when to refer to them.
• High level of knowledge and experience using ARGUS, MedDRA, and RAVE/Trial Access Online/J-Review.
• In depth Knowledge of computer applications and project planning skills.
• Mastery of GPV&E and R&D SOPs, drug safety coding conventions, and work.
• Provide technical support to GPV&E medical review safety physicians (MRSP) including review and interpretation of source documents.
• Participate in the evaluation of serious adverse event reports from spontaneous reports, clinical trials, non-clinical reports and scientific literature.
• Identify additional information required from investigators and collaborate with MRSP to prepare queries to obtain additional information.
• Utilize ARGUS database and J-Review to prepare contextual summaries for expedited safety reports.
• Review and comment on documents and line listings from GPV&E, other Client departments, and other drug development/marketing partners and contractors.
• Ad Hoc member of Medical Surveillance Team.
• Perform Analysis of Similar Events for potential DILI and events of special interest.
• Serve as a resource for GPV&E information and help develop and participate in and/or lead teams involved with developing or revising GPV&E SOPs.

How to Apply

Job Types: Temporary.

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