The Role
Conduct timely alert triage and signal validation by reviewing case and aggregate safety data from clinical, post-marketing, literature, and quality sources. Support signal evaluation, develop post-marketing surveillance strategies and product-specific safety assessments, participate in cross-functional teams, evaluate novel analysis tools, track signal management activities, and maintain related documentation.
Summary Generated by Built In
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
Skills Required
- Board-certified medical physician
- Ability to analyze, interpret, and present complex scientific data orally and in writing
- Proficiency in MS Office applications
- Diligence in record-keeping, records organization, and ability to manage high workload
- Strong interpersonal, communication, presentation, and cross-functional collaboration skills
- At least one year of clinical experience or experience in pharmaceutical medicine
ClinChoice Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ClinChoice and has not been reviewed or approved by ClinChoice.
-
Flexible Benefits — Flexible arrangements, including telecommuting and flextime with no core hours in some regions, are highlighted for many roles. Feedback suggests flexibility is commonly available but depends on role and location.
-
Leave & Time Off Breadth — Vacation, personal, and sick days are part of the core package, with some markets granting paid leave from the date of hire. Feedback suggests time off is standard-to-decent across locations, though specifics vary.
-
Healthcare Strength — Health coverage is positioned as a core benefit, with some accounts describing overall benefits as full or good. In the U.S., healthcare sits within a conventional CRO package alongside medical, dental, and vision.
ClinChoice Insights
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
The Company
What We Do
ClinChoice is a global full-service Contract Research Organization (CRO) specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies, aiming to accelerate the development and commercialization of innovative drugs and devices.
