Assoc MDR Vigilance Specialist

Associate MDR / Vigilance Specialist

Hybrid

12 months Contract Role

Role Overview

The Associate MDR / Vigilance Specialist supports the company's drug and medical device surveillance activities. This role focuses on the intake, evaluation, processing, and reporting of adverse events, ensuring compliance with global regulatory requirements. The position is an entry-level individual contributor role within the Specialist Career Stream, working under close supervision.

Key Responsibilities

Responsibilities may include, but are not limited to:

• Monitor the company's drug and medical device surveillance program, including:
  • Intake and processing of adverse event reports
  • Protocol development and follow up activities
• Ensure complete, accurate, and timely maintenance and submission of:
  • Medical Device Reports (MDRs)
  • Adverse Drug Experience (ADE) data
  • Adverse reaction data, as required by regulatory agencies
• Review and analyze clinical databases to extract ADE data
• Integrate safety data into a unified database to support ADE standardization and internalization
• Ensure accuracy and quality of safety summaries and reports
• Support compliance with applicable government regulations
• Participate in activities related to legal liability resolution when required
• Act as an internal and external liaison to support the development of programs and processes that meet regulatory reporting requirements

Career Stream

Specialist

• Typically an individual contributor within a professional discipline or specialty
• Delivers assigned projects and collaborates with stakeholders to achieve objectives
• May support or mentor colleagues or direct work of lower level professionals
• Majority of time spent delivering and overseeing projects from design to implementation
• Applies specialized knowledge while adhering to established policies and procedures

Role Characteristics

Autonomy

Entry level individual contributor

Works under close supervision as part of a project or work team

Organisational Impact

Delivers work of limited scope

Supports smaller, less complex projects or related activities

Innovation & Complexity

Identifies and addresses problems that may not be immediately evident

Problems are typically straightforward

Makes minor system or process improvements to resolve issues

Communication & Influence

Communicates primarily with internal contacts within the immediate team

Gathers, confirms, and conveys information to support team objectives

Leadership & Talent Management

Not applicable

Role is focused on individual contribution and self development

Required Knowledge & Experience

• Broad theoretical job knowledge typically obtained through advanced education
• Bachelor's degree (Baccalaureate) required
• For degrees earned outside the United States, must meet the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A)
• No prior professional experience required