Drug Safety Associate-Ii

Parexel

Minimum 2 years years

upto 7.5 LPA

Mohali

20 July 11, 2024

Job Description

Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D, Nursing Skills: Causality Assessment, Communication Skills, GCP guidelines, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Drug Safety Associate-II

Company Name: Parexel

Locations

India-Mohali

Time Type

Full time

Posted On

Posted Today

Job Requisition ID

R0000023755

Job Description:

Key Accountabilities:

Drug Safety Support

Assist in the 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.
Perform 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.
Write 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 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.
Assist in the development of Expedited Reporting Procedures.
Assist with registration with relevant authorities for electronic reporting on behalf of sponsor.
Assist with setting up and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy).
Submit safety reports to investigators via ISIS (International Safety Information System).
Assist with measuring investigative site performance in conducting required tasks in ISIS.
Track and file 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.
Ability 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

Minimum 2 years experience in ICSR case processing.

Education

Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification.

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