Full-Time
Salary: 25k to 30k
Positions: 10

Pharmacovigilance Services Associate

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Job Description

 Location: Bengaluru, Karnataka, India
Job ID: R-236736
Job Type: Full-Time

Introduction

 This role ensures the effective execution of study delivery processes across clinical studies from start-up to reporting. The Clinical Research Associate serves as the main contact for study documentation and supports the production, compliance, and management of clinical-regulatory documents, ensuring high-quality delivery in accordance with company policies and regulations.

Role & Responsibilities

  • Execute study delivery processes through development of study report tools and maintenance of the study delivery system.

  • Deliver centrally managed study management services across clinical studies from start-up to reporting.

  • Serve as the main contact and liaise with the Document Management group until the Clinical Study Report is finalized. 

  • Initiate and maintain production of study documents, ensuring template and version compliance.

  • Create or import clinical-regulatory documents into the Global Electronic Library according to the Global Document List.

  • Monitor administrative tasks, audits, and regulatory inspections according to company policies. 

Educational Qualification

  • Essential: Bachelor’s degree in a relevant discipline; experience in study management within a pharmaceutical or clinical background; knowledge of relevant legislation and developments in clinical development and study management.

  • Desirable: Advanced degree; professional certification; understanding of multiple aspects within study management.

    Experience & Skills

  • Experience in study management, documentation handling, and compliance within clinical trials. • Strong organizational, communication, and interpersonal skills.

  • Attention to detail and ability to work independently.

  • Knowledge of global and local regulations related to clinical study management.

Location

 Bengaluru, Karnataka, India

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