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