Job Description

• Performance of alert triage within pre-defined timelines, by conducting systematic reviews of cases and aggregate data in the safety databases and reviewing trends, as applicable, to identify potential safety signals.
• Performance of signal validation and support for signal evaluation through the review, analysis, interpretation, and summary of case and aggregate safety data from various sources such as clinical, post marketing, observational studies, medical literature, health authority databases, and product quality databases.
• Assistance in the development and implementation of strategies for the surveillance of post-marketing data, as well as the development of product-specific medical safety assessments.
• Participation as a member of the matrix teams to address product-specific safety issues.
• Support for the evaluation of novel and computer-assisted tools and methodologies for the analysis of safety data.
• Tracking of signal disposition and signal management activities in the relevant tracking tool.
• Support for maintenance of documentation relevant to signal detection and management activities

Education/Qualifications:

• Requirement: board-certified medical physician
• Technical Skills: the ability to analyze, interpret, and present complex data in a concise and understandable scientific manner, both orally and in written format, is essential
• Attention to detail: diligence in record-keeping and records organization, ability to manage a high workload and critical issues, computer-literate and proficient in MS Office applications
• Interpersonal skills: team player, displays initiative, strong communication, and presentation skills
• Internal and external networking skills: strong collaborative and interpersonal skills, results-oriented and ability to independently create and deliver, ability to thrive in a global, cross-functional environment
• At least one year of clinical experience or experience in pharmaceutical medicine, is preferred