Drug Safety Associate

2 days ago

Hyderabad, India Parexel Full time

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

Assist with additional Drug Safety Specialist on 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

Support Global Pharmacovigilance Information Office (GPIO) in the collection and organization of global PV requirements
** Qualifications**: 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

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