Job Description

Job Description

Job Description

Salary: $23/hour

Overview

The Drug Safety intern would work in a team-oriented, dynamic, and collaborative environment. This intern would become knowledgeable about key safety guidance, including Good Clinical Practices (GCPs) and Good Pharmacovigilance Practice (GVP), regulatory guidelines, and company and project/program-specific protocols. The intern would gain exposure to various safety operations, including receipt of safety information, monitoring of the safety mailboxes, case processing, and regulatory submission tracking. The intern would support drug safety activities and contribute to maintaining compliance with standard operating procedures and with national and international regulations for the reporting of adverse events to regulatory agencies.

Responsibilities

• Review the protocols of current Iovance-sponsored trials, expanded use program, and investigator-initiated trials and create a comprehensive reference document.
• Assist with inspection readiness by verifying regulatory submission tracker data against the data stored in the safety database and internal folders.
• Collaborate with the Drug Safety operations team to action and archive emails and documents received to the safety mailboxes.
• Demonstrate basic knowledge of case management, including receipt of safety information, book-in, assessment of seriousness and expectedness, and general data entry conventions.
• Recognize various case types and recognize safety information requiring expedited reporting.
• May assist drug safety managers with other projects including but not limited to the preparation of training materials, global PV system compliance, and vendor management activities.

Education

Bachelors degree in sciences or student in a health science area (pharmacy, nursing)

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