Associate MDR / Vigilance Specialist.

Associate MDR / Vigilance Specialist 24 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