宜昌招聘

POSITION DESCRIPTION: The Clinical Safety Specialist will work with other members of the MCO Clinical Safety team located around the world, Clinical Operations, Data Management, Quality Assurance and Regulatory Affairs to manage death and adverse event reporting in compliance with applicable regulatory standards and Medtronic internal requirements.

POSITION RESPONSIBILITIES:

? Review and triaging clinical trial deaths and adverse events (AEs) including serious adverse events (SAEs).

? Conduct Case Management in the Clinical Safety Database.

? Interacts with investigational sites and field monitors to obtain additional pertinent information as indicated.

? Works with the clinical project team to ensure consistency in the assessment, recording and coding of clinical safety events (e.g., SAEs , adverse events (AEs), and device deficiencies). .

? Works with Regulatory Affairs, Clinical Operations and Field Assurance to ensure timely reporting of AEs, SAEs and UADEs including expedited and annual reporting and other documents as needed.

? Ensures appropriate distribution and notification of SAEs and UADEs to appropriate personnel, partners, and clinical centers for protocol(s).

? Liaison for safety-related questions ( e.g., to study team, field support, monitors, and study sites)

? Write Clinical Safety plan for assigned protocol(s).

? Assists with preparation of assigned section of safety reports for annual reports, clinical study reports, investigator brochure updates, and other documents as required.

? Collaborates with data management and other departments on the development of case report forms, study specific safety reports, and other study specific forms.

? Assists with the writing of safety sections of clinical protocols and may present safety monitoring at investigator meetings.

? Performs other duties as assigned.

BASIC QUALIFICATIONS:

? Good written, oral, and interpersonal communication skills including knowledge of medical terminology.

? Proficient with MS Office products, word processing, spreadsheets, etc.

? High attention to detail and accuracy and ability to manage multiple tasks.

? Good prioritization and organizational skills.

? Excellent problem solving skills

? Flexible and dependable.

? Works effectively on cross-functional teams.

EDUCATION REQUIRED:

? Bachelor’s degree

YEARS OF EXPERIENCE

? 2+ yrs safety experience

SPECIALIZED KNOWLEDGE REQUIRED

? Basic knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.

? Fluent with medical terminology

DESIRED/PREFERRED QUALIFICATIONS (optional)

? RN, PA, PharmD, RPh, PhD, MD, DO, or allied health professional including Biomedical Engineer, Biomedical Scientist .

? Thorough understanding of the general clinical research process with broad knowledge of GCP reporting guidelines, regulatory agency (US and OUS as is appropriate) regulations

PHYSICAL JOB REQUIREMENTS

? The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

? While performing the duties of this job, the employee is regularly required to be independently mobile with up to 10% of time traveling outside of the office. The employee is also required to interact with a computer, and communicate with peers and co-workers.

About Medtronic
Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.

We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.