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