Drug Safety Associate- Case processing

Updated: March 06, 2024 07:28 PM GMT

Full time Job in Kodigehalli, Karnataka

BiosTec

Bangalore, Karnataka, Inde

Profile description:

BiosTec is looking for candidates who can fill the position of Drug Safety Associate. The role will be involved in the below mentioned activities.
• Recording individual case safety reports (ICSR) from various sources
• Triage and process safety data in the safety database
• Ensure accurate coding of medical terminologies using MedDRA (medical dictionary for regulatory activities) and assess the causal association
• Prepare appropriate narratives and generate follow up queries related to each case report
• Perform quality check to ensure overall consistency of case processing and related activities
• Timely submission of case reports as per regulatory requirements
• Tracking and archival of pharmacovigilance documents
• Assisting in audit and inspection
• Develop, review and update relevant standard operating procedures/work instructions related to pharmacovigilance activities

Candidate specifications:

Education and experience:
• Life science graduate with 3-4... More Detail