Patient Safety Specialist Job

PATIENT SAFETY SPECIALIST needed for a CONTRACT opportunity with Yoh's client located in WILMINGTON, DE.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Five years of experience in a hospital, pharmaceutical, clinical research position, or other healthcare related field, to include at least two years experience in Patient Safety
- Bachelor's degree in science/healthcare related field or proven Patient Safety experience equivalence in a similar role, and an excellent clinical background. Advanced degree is preferred
- Demonstrated working knowledge of FDA and ICH regulations relevant to Patient Safety and adverse event reporting
- Broad competence with medical, therapeutic and technical terminology

WHAT YOU'LL BE DOING:

- Participates in the triage process for incoming documents to insure timely and effective medical and scientific evaluation of adverse event information
- Request follow-up information from consumers, and health care professionals and requests clarification from foreign affiliates according to specific report types using both global and local SOP timeframes
- Reviews adverse event documents prepared by the Patient Safety personnel for accuracy, completeness, and validity prior to submission to the FDA
- Enter and maintain accurate tracking system for all AE reports (CRIMSON/Jasper)
- Have a broad understanding of Surveillance activities and the impact on individual case or group of cases can have on product labeling
- Leads team in preparing, organizing, and reviewing tabulations for Regulatory reports
- Assumes responsibility for completing special projects (ieDSURs, PSUR table preparation)
- Supports Safety Surveillance, Safety Support - Compliance and Marketing Company and US Medical Affairs and the US Clinical Teams
- Serves as a knowledge resource for departmental personnel regarding medical, scientific and Operational issues
- Demonstrates ability to communicate effectively with personnel of various disciplines regarding aspects of product inquiries and collection of safety data
- Reflects the Patient Safety philosophy of being a team player and supports the development of those individuals within the department
- Working knowledge of technology required for Patient Safety
- Initiates and volunteers for special projects

WHAT YOU NEED TO BRING TO THE TABLE:

- Demonstrates leadership capabilities at target level or above.
- Able to work effectively as part of a cross functional team
- Excellent verbal and written communication skills

WHAT'S IN IT FOR YOU?

Work for a multinational pharmaceutical and biologics company having a portfolio of products for major disease areas including cancer, cardiovascular, gastrointestinal, infection, neuroscience, respiratory and inflammation.

WHAT ARE YOU WAITING FOR? APPLY NOW!

Yoh, a DayJ2W: SCIENTIFIC; MONJOB

TAX TERM: CON_W2J2WNECLIN

Ref: AZNJP

SFSF: LS