Patient Safety Specialist Job

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

TOP SKILLS SHOULD YOU POSSESS:

- Patient Safety

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
- Excellent knowledge of FDA and ICH guidelines and reporting requirements
- Initiates and volunteers for special projects
- Demonstrates leadership capabilities at target level or above

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelor's Degree in Science/Healthcare related field or proven Patient Safety experience equivalence in a similar role, and an excellent clinical background.
- 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
- Demonstrated working knowledge of FDA and ICH regulations relevant to Patient Safety and adverse event reporting
- Broad competence with medical, therapeutic and technical terminology
- Able to work effectively as part of a cross functional team
- Excellent verbal and written communication skills
- Demonstrated capabilities in the following:
- Project management
- Time management
- Presentation skills
- Strong attention to detail and organization

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- Advanced degree is preferred

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a DayTHIS ADDRESS IS EXCLUSIVELY FOR INDIVIDUALS WITH DISABILITIES REQUESTING APPLICATION ASSISTANCE.

J2W: HC

MONJOBJ2WMIDATL

Ref:

SFSF: LS