Patient Safety Associate 1

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Key Accountabilities:

Drug Safety Support:

• Assist in development of project specific safety procedures, workflows and template

• Assist in project specific safety database setup, development of data entry guidelines, and user acceptance testing

• Triage incoming reports for completeness, legibility, and validity

• Electronic documentation and quality control of drug safety information

• Data entry of case reports into safety database / tracking system

• Request follow-up and perform query management

• Coding of data in the safety database

• Writing case narratives

• Create and maintain project specific working files, case report files and project central files

• Assist with additional Drug Safety Specialist and/or Safety Service Project Leader (SSPL) activities as required

• Inform Line Manager (LM)/Team Manager, Safety Services Project Leader (SSPL) or Project Leader (PL) and Regional Head of PV Operations of potential change-in-scope of projects

• Support of Medical Directors/Safety Physicians, as needed, in medical monitoring activities

• Participate in client and investigator meetings as required

• Attend internal, drug safety and project specific training sessions

• Perform literature searches

• Preparation for, participation in, and follow up on audits and inspections

• Delegate work as appropriate to Drug Safety Assistants

• Assistance in development of Expedited Reporting Procedures

• Assistance with registration with relevant authorities for electronic reporting on behalf of sponsor

• Assistance with setting up and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy)

• Submission of safety reports to investigators via ISIS (International Safety Information System)

• Assist with measuring investigative site performance in conducting required tasks in ISIS

• Tracking and filing of submission cases as required

• Assist with unblinding of SUSARs, as required

• Support collection and review of metrics for measuring reporting compliance

Skills:

• Analytical and problem-solving skills

• Able to perform database/literature searches

• Excellent interpersonal skills

• Excellent verbal / written communication skills

• Excellent organizational and prioritization skills

• Ability to work collaboratively and effectively in a team environment

• Client focused approach to work

• Experience with computer applications

Knowledge and Experience:

• Related experience gained in a healthcare environment is an advantage

Education:

• Masters/Pharm D Degree in Pharmacy, Nursing, Life Science or other health-related field, or equivalent qualification/work experience