Patient Safety Associate I at Parexel

Hyderabad, Andhra Pradesh, India -

Full Time

Start Date

Immediate

Expiry Date

16 Feb, 26

Salary

0.0

Posted On

18 Nov, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Analytical Skills, Problem-Solving Skills, Database Searches, Literature Searches, Interpersonal Skills, Verbal Communication, Written Communication, Organizational Skills, Prioritization Skills, Team Collaboration, Client Focus, Computer Applications

Industry

Pharmaceutical Manufacturing

Description

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. Job Description 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: Degree in Pharmacy, Nursing, Life Science or other health-related field, or equivalent qualification/work experience Associates degree in any of the above with appropriate work experience Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.

Responsibilities

The Patient Safety Associate I will assist in the development of project-specific safety procedures and workflows, as well as manage incoming reports and data entry into safety databases. Additional responsibilities include supporting medical monitoring activities and participating in audits and inspections.