Patient Safety Associate I

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.

The Patient Safety Associate I provides technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs). 
Responsible for one or several of the following: processing of Individual Case Safety Reports (ICSRs) from various sources, Literature search and review, signal detection and management, tracking regulatory information, performing regulatory submissions and supporting preparation of aggregate and other study reports, as well as Medical and Product Dictionary Management activities, where applicable 
Responsible for compliance and related processes including but not limited to quality review of deliverables, metrics generation and late deliverable investigation in accordance with International and local regulatory reporting requirements, where applicable
 

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:

• Postgraduate in Pharmacy, Pharmacovigilance & Clinical Research/Bachelor in Dentistry