Mdr/vigilance Specialist I

At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all You ll lead with purpose breaking down barriers to innovation in a more connected compassionate world A Day in the Life Responsibilities may include the following and other duties may be assigned Monitors the company s drug or medical devices surveillance program including the intake protocol development evaluation processing and follow-up on adverse reports participation in the resolution of any legal liability and in complying with government regulations Ensures complete and accurate maintenance and reporting of Medical Device Reports MDRs Adverse Drug Experience ADE data or adverse reaction data as required by regulatory agencies Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements SPECIALIST CAREER STREAM Typically an individual contributor with responsibility in a professional discipline or specialty Delivers and or manages projects assigned and works with other stakeholders to achieve desired results May act as a mentor to colleagues or may direct the work of other lower level professionals The majority of time is spent delivering and overseeing the projects - from design to implementation - while and adhering to policies using specialized knowledge and skills normally acquired through advanced education DIFFERENTIATING FACTORS Autonomy Entry-level individual contributor on a project or work team Works with close supervision Organizational Impact Delivers work of limited scope typically smaller less complex projects or related activities Innovation and Complexity Identifies defines and addresses problems that are not immediately evident but typically not difficult or complex Makes minor changes in systems and processes to solve problems Communication and Influence Communicates primarily with internal contacts within immediate group Contacts others to gather confirm and convey information Leadership and Talent Management N A - job at this level is focused on self-development Required Knowledge and Experience Requires broad theoretical job knowledge typically obtained through advanced education Requires a Baccalaureate degree or for degrees earned outside of the United States a degree which satisfies the requirements of 8 C F R 214 2 h 4 iii A 0 years of experience required Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position Benefits Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values We recognize their contributions They share in the success they help to create We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions Our Mission to alleviate pain restore health and extend life unites a global team of 95 000 passionate people We are engineers at heart putting ambitious ideas to work to generate real solutions for real people From the R D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves We have the talent diverse perspectives and guts to engineer the extraordinary Learn more about our business mission and our commitment to diversity