- 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.
- 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:
- Project management.
- Time management.
- Presentation skills:
- Strong attention to detail and organization.
- Five years of experience in a hospital, pharmaceutical, clinical research position, or other healthcare related field, to include at least 3 years of Patient Safety experience.
- Works as a team player and supports the development of other team members.
- Excellent knowledge of FDA regulations and ICH guidelines.
- Provides training and mentoring of Patient Safety staff on local and global adverse event reporting, project work and with respect to career development.
- Demonstrates leadership ability by conducting team meetings independently and managing special projects.
- Assumes a lead role in identifying Patient Safety related issues and is instrumental in implementing solutions to those issues.
- Assumes back-up support for the Patient Safety Operations Manager/Director to meet/maintain departmental objectives.
- Assumes a lead role in supporting the business unit needs and Patient Safety by actively developing and maintaining partnerships with internal and external customers.
- Serves as a Patient Safety representative on various local, global and clinical teams.
- Supports the Patient Safety Operations Managers in performance management review of team members.
- Assumes a lead role in the interview process for prospective new team members.
- Demonstrates an active interest in pursuing continuing education within the Pharmaceutical Industry.
The US Patient Safety Specialist serves as a Medical and Safety resource for synthesis, analysis, evaluation, and reporting of adverse event information in order to maintain an accurate safety profile of Client products. The US Patient Safety Specialist serves as vital link in the timely classification, analysis and summarization of both investigational and post-marketed adverse event information and support to the product teams. The US Patient Safety Specialist supports the multidisciplinary teams and other cross-functional teams within Client to provide case handling and safety support to licensing agreements, clinical study agreements and special projects.
- 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 (Jasper).
- Have a broad understanding of Support & Surveillance activities and the impact on individual case or group of cases can have on product labelling.
- Leads team in preparing, organizing, and reviewing tabulations for Regulatory reports.
- Represents US Patient Safety in Licensing Agreement review and process teams.
- Represents US Patient Safety for Clinical Trial protocol and safety handling plan review and process teams.
- Assumes responsibility for completing special projects (i.e. CIPs, representation on cross functional teams).
- 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, collection of safety data and FDA / Client processes and regulations.
- 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.
- Demonstrated ability to perform with minimal supervision.
- Demonstrates leadership capabilities at target level or above.
- Ability to travel domestically for yearly business meeting.
This 12+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Cheryl: firstname.lastname@example.org
ALPHA'S REQUIREMENT #19-00763
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE #ZR