Drug Safety Associate

Drug Safety Associate

Parexel International (India) Pvt. Ltd.
Not Specified
Not Specified

Job Description



Assist in development of project specific safety procedures, workflows and templates
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
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
Assist with additional Drug Safety Specialist and/or Medical Operations Leader (MOL) activities as required
Inform Line Manager (LM)/Team Manager, Medical Operations Leader (MOL) 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
Qualifications
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
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

Job Details

Employment Types:

Industry:

We know just how important it is to put people first. It's with that human touch that we've played a part in nearly all of the top 50 treatments on the market. And every day, we're focused on working with industry leaders to bring life-changing healthcare to patients across the globe. Whether you join our Clinical, Consulting, Biotech, Functional Service Provider (FSP), or other teams, we're doing it With Heart ™.

Job Source : jobs.parexel.com

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