Assoc MDR Vigilance Specialist
We are seeking a highly skilled Assoc MDR Vigilance Specialist to join our team on an initial 12-month contract. This is a hybrid role with 2 days in the office per week.
Responsibilities:
* Monitors and manages the company's drug or medical devices surveillance program, including intake, protocol development, evaluation, processing, and follow-up on adverse reports.
* Participates in the resolution of any legal liability and ensures compliance with government regulations.
* Maintains and reports Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data, and adverse reaction data as required by regulatory agencies.
* Reviews and analyzes clinical databases for ADE data extraction and integrates the data to create a unified database consistent with standardization and internalization goals.
Requirements:
* Bachelor's degree in Engineering/Science/Legal/Clinical or related discipline.
* 1-2 years of relevant experience in a medical devices or related environment (preferably).
* Dynamic team player who can work effectively and proactively on cross-functional teams.
* Ability to think critically and make sound decisions.
* Strong attention to detail.
* Knowledge of basic anatomy, physiology, and medical terminology.
* Focused on patient safety and customer service, setting high standards and driving accountability.
* Good communicator and fluent in English (written and spoken).