Associate MDR/Vigilance Specialist

7 days ago

Mounds View, United States Planet Pharma Full time

GREAT OPPORTUNITY FOR FRESH GRADS TO GAIN EXPERIENCE WITH A GLOBAL INDUSTRY LEADING MEDICAL DEVICE COMPANY



Top Needs:

1. Attention to detail

2. Critical thinking skills

3. Excellent written communication skills


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 ndash 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 ndash 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. sect 214.2h 4iiiA

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