Associate MDR / Vigilance SpecialistHybrid12 months Contract RoleRole OverviewThe 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 ResponsibilitiesResponsibilities may include, but are not limited to:Monitor the company's drug and medical device surveillance program, including:Intake and processing of adverse event reportsProtocol development and follow-up activitiesEnsure complete, accurate, and timely maintenance and submission of:Medical Device Reports (MDRs)Adverse Drug Experience (ADE) dataAdverse reaction data, as required by regulatory agenciesReview and analyze clinical databases to extract ADE dataIntegrate safety data into a unified database to support ADE standardization and internalizationEnsure accuracy and quality of safety summaries and reportsSupport compliance with applicable government regulationsParticipate in activities related to legal liability resolution when requiredAct as an internal and external liaison to support the development of programs and processes that meet regulatory reporting requirementsCareer Stream: SpecialistTypically an individual contributor within a professional discipline or specialtyDelivers assigned projects and collaborates with stakeholders to achieve objectivesMay support or mentor colleagues or direct work of lower-level professionalsMajority of time spent delivering and overseeing projects from design to implementationApplies specialized knowledge while adhering to established policies and proceduresRole CharacteristicsAutonomyEntry-level individual contributorWorks under close supervision as part of a project or work teamOrganisational ImpactDelivers work of limited scopeSupports smaller, less complex projects or related activitiesInnovation & ComplexityIdentifies and addresses problems that may not be immediately evidentProblems are typically straightforwardMakes minor system or process improvements to resolve issuesCommunication & InfluenceCommunicates primarily with internal contacts within the immediate teamGathers, confirms, and conveys information to support team objectivesLeadership & Talent ManagementNot applicableRole is focused on individual contribution and self-developmentRequired Knowledge & ExperienceBroad theoretical job knowledge typically obtained through advanced educationBachelor's degree (Baccalaureate) requiredFor 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