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Drug Safety Associate I & II

Salary

3.5k LPA - 6k LPA

Min Experience

1 years

Location

Hyderabad, Mohali

JobType

full-time

About the job

Info This job is sourced from a job board

About the role

Are you looking for a rewarding career in Pharmacovigilance (PV)? Parexel is hiring Drug Safety Associates (I & II) in Hyderabad and Mohali, India. If you have a background in pharmacy, nursing, or life sciences with 1+ years of PV experience, this could be your next big opportunity! Key Responsibilities: Assist in drug safety management (clinical trial & post-marketed) and medical monitoring activities. Support safety database setup, data entry guidelines, and user acceptance testing (UAT). Triage and process adverse event reports for completeness and validity. Perform data entry, quality control, and case narrative writing in safety databases. Manage follow-up requests, query resolution, and coding in safety databases. Assist in preparing for audits, inspections, and regulatory submissions. Support medical directors and safety physicians in medical monitoring tasks. Participate in client meetings, investigator meetings, and internal training sessions. Conduct literature searches and assist in expedited reporting procedures. Track and ensure compliance with global regulatory submissions.

About the company

Parexel is a leading global clinical research organization (CRO) dedicated to improving patient health through innovative drug development solutions. From clinical trials to regulatory consulting, Parexel's work impacts millions of lives worldwide.

Skills

Pharmacovigilance
Data Entry
Quality Control
Case Narrative Writing
Regulatory Submissions