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About Company

At Parexel, we share the goal of improving global health. From clinical trials to regulatory, consulting, and market access, our clinical development solutions are driven by a deep conviction in our mission. Each role at Parexel contributes to the development of therapies that ultimately benefit patients, making our work personal, empathetic, and committed to making a difference.

Position Name :

Drug Safety Associate I

Organization :



BDS, M.Pharm


0 YEARS / Freshers - 2 Year


₹4.9 Lakhs per year


Chandigarh, India (Office Based)

The Drug Safety Associate I will support drug safety management and medical monitoring activities for clinical trials and post-marketed products, ensuring compliance with relevant regulations and SOPs.

Key Accountabilities:

  • Drug Safety Support:
    • Assist in developing project-specific safety procedures, workflows, and templates.
    • Aid in safety database setup, data entry guidelines development, and user acceptance testing.
    • Triage incoming reports for completeness and validity.
    • Document and quality control drug safety information electronically.
    • Enter case reports into safety database/tracking system.
    • Manage follow-up requests and queries.
    • Code data in the safety database.
    • Write case narratives.
    • Maintain project-specific working files and case report files.
    • Support Drug Safety Specialists and Safety Service Project Leaders as required.
    • Inform managers of potential project scope changes.
    • Support Medical Directors and Safety Physicians in medical monitoring.
    • Participate in client and investigator meetings.
    • Attend training sessions.
    • Perform literature searches.
    • Prepare for and follow up on audits and inspections.
    • Delegate work to Drug Safety Assistants.
    • Develop Expedited Reporting Procedures.
    • Register with authorities for electronic reporting on behalf of sponsors.
    • Set up and deploy worldwide reporting to regulatory authorities.
    • Submit safety reports to investigators.
    • Track and file submission cases.
    • Assist with unblinding of SUSARs.
    • Review metrics for reporting compliance.


  • Analytical and problem-solving skills.
  • Ability to perform database/literature searches.
  • Excellent interpersonal, verbal, and written communication skills.
  • Strong organizational and prioritization skills.
  • Ability to work effectively in a team environment.
  • Client-focused approach.
  • Experience with computer applications.

Application Link