Sr. Clinical Safety Specialist

Medtronic. Careers with a passion for life.
As the world’s leading medical technology company, we provide lifelong solutions to people with chronic disease. Everything we do is deeply rooted in our mission—to alleviate pain, restore health, and extend life. Every 5 seconds the life of someone somewhere in the world is improved by a Medtronic product or therapy. We also are dedicated to the total well-being of our employees and have been recognized for seven of the last nine years by Fortune magazine as one of the "100 Best Companies to Work For in America." Work with the kind of people who not only love what they do but why they do it.

Sr. Clinical Safety Specialist
Northridge, California

Tracking adverse events within Clinical trials; compile data for presentation to safety committee.

Receiving and processing all adverse event reports.
Reviewing and being familiar with all study protocols for U.S. clinical trials. Entering safety data from serious adverse events. Interacting with project monitors and site staff to create safety narratives and modify database as appropriate. Investigating, tracking and resolving all queries. Identifying, reporting, assessing and resolving safety issues on individual reports with the Safety Committee.
REQUIREMENTS
JOB QUALIFICATIONS: TECHNICAL:Excellent written and oral communication skills. Working knowledge of FDA and ICH guidelines and regulations relating to safety reporting and/or pharmacovigilance. Must have database management experience. Knowledge of medical terminology. Advanced project management skills. Good computer skills (MS Office products, word processing, spreadsheets, internet, e-mail). CONCEPTUAL: High attention to detail and accuracy. Able to manage multiple tasks. Excellent prioritization and organizational skills. Excellent problem solving skills. INTERPERSONAL: Positive flexible outlook.
Excellent interpersonal communication skills. Works effectively on cross-functional teams. Presents in professional manner and appearance. PHYSICAL REQUIREMENTS: Must be able to Travel EDUCATIONAL/EXPERIENCE REQUIREMENTS: Bachelor’s degree in biological sciences, nursing or related medical/scientific field required. Prefer: Min 6 Years with B.A. or Min 4 Years with MastersMinimum 3 years experience in the medical device industry or equivalent combination of education and experience.

We are currently seeking multiple individuals for Clinical Studies opportunities throughout Medtronic. Qualified candidates with all levels of experience are encouraged to submit an application in consideration for this or similar opportunities. This opportunity is based in Northridge, California. Other opportunities may also exist at our locations in Minneapolis, Minnesota; Santa Rosa, California; Redmond, Washington; Denver (Louisville), Colorado; Ft. Worth, Texas; Memphis, Tennessee; Danvers, Massachusetts; and Jacksonville, Florida.

With people like you who have purpose, potential and passion, we’ll supply physicians and their patients around the world with the means to alleviate pain, restore health and extend life.

TO APPLY: Please submit your resume at www.medtronic.com/employment. Review Clinical Studies openings or enter Requisition # 52300 and select "Add to Cart" or "Apply to this Job" to route your resume directly to the hiring department. No agencies or phone calls, please.

Medtronic is an equal opportunity employer committed to cultural diversity in the workforce.