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Drug Safety Associate I

Freshers years
2-4 LPA
10 Dec. 23, 2024
Job Description
Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D Skills:

Drug Safety Associate I

Company: Parexel
Location: India - Mohali
Time Type: Full-Time
Posted On: 5 Days Ago
Job Requisition ID: R0000029944


About Parexel

At Parexel, we share a unified goal: to improve global health. Through clinical trials, regulatory consulting, and market access solutions, we provide innovative clinical development services. Our commitment is rooted in a deep conviction in what we do. Every team member, regardless of their role, contributes to developing therapies that benefit patients worldwide.

With empathy and dedication, we strive to make a tangible difference in healthcare.


Position Overview

The Drug Safety Associate I supports technical and process-related aspects of drug safety management, including clinical trial and post-market activities. The role ensures compliance with regulations and Standard Operating Procedures (SOPs) while contributing to drug safety monitoring and reporting.


Key Responsibilities

Drug Safety Support:

  • Assist in creating project-specific safety procedures, workflows, and templates.
  • Support safety database setup, data entry guidelines development, and user acceptance testing.
  • Triage incoming reports for completeness, legibility, and validity.
  • Perform electronic documentation and quality control of drug safety information.
  • Enter case reports into safety databases/tracking systems and manage follow-ups or queries.
  • Conduct coding of data in the safety database and draft case narratives.
  • Create and maintain project-specific files, including case report files and central project files.
  • Participate in literature searches and audits/inspections preparation, as required.

Collaboration and Monitoring:

  • Inform managers of potential project scope changes and assist Safety Service Project Leaders (SSPL).
  • Provide medical monitoring support to Medical Directors/Safety Physicians.
  • Collaborate with clients, investigators, and teams during meetings and training sessions.
  • Assist with expedited reporting procedures and worldwide regulatory reporting setup.

Documentation and Reporting:

  • Submit safety reports to investigators via the International Safety Information System (ISIS).
  • Track and file submission cases and unblind SUSARs, as required.
  • Support metrics collection for reporting compliance measurement.

Skills and Competencies

  • Strong analytical and problem-solving abilities.
  • Proficiency in database and literature searches.
  • Exceptional interpersonal, organizational, and communication skills.
  • Ability to collaborate effectively in team settings with a client-focused approach.
  • Competence in using computer applications.

Qualifications

  • Education: M. Pharmacy, BDS, Pharm D, or equivalent qualification/work experience.
  • Experience in a healthcare environment is advantageous.

Why Join Parexel?

At Parexel, you’ll be part of a diverse, collaborative, and inclusive team dedicated to making a difference. This role offers opportunities for professional growth while contributing to improving global health.

Apply now to become part of a team shaping the future of healthcare!