CQV Drug Safety Data Associate

United Consulting Hub, Inc.; New Jersey; On-site; USD 60,000 - 80,000; Full time

Job summary

United Consulting Hub, Inc. is seeking a detail-oriented Drug Safety Data Associate to support pharmacovigilance and drug safety operations. The role involves reviewing adverse event information, maintaining safety databases, and ensuring accurate documentation of drug safety records.

You will assist in collecting adverse event data, review safety reports for completeness, and help prepare ICSRs and case trackers in accordance with SOPs.

Qualifications

• Basic understanding of pharmacology and drug safety.
• Familiarity with adverse event reporting processes.
• Strong data entry and meticulous documentation skills.
• Good analytical and written/oral communication abilities.

Responsibilities

• Assist in collecting and processing adverse event information.
• Review drug safety reports for accuracy and completeness.
• Support data entry into pharmacovigilance databases.
• Assist in preparing Individual Case Safety Reports (ICSRs).
• Maintain drug safety records and case processing trackers.
• Support medical literature screening activities.
• Track safety reporting timelines and documentation.
• Follow company SOPs and applicable pharmacovigilance guidelines.

Skills

Pharmacology basics

Adverse event reporting

Data entry

Documentation

Excel & Word

Tools

Microsoft Excel

Microsoft Word

Job description

We are looking for a detail-oriented Drug Safety Data Associate to support pharmacovigilance and drug safety operations in pharmaceutical and biotechnology organizations. The candidate will assist in reviewing adverse event information, maintaining safety databases, and ensuring accurate documentation of drug safety records.

Key Responsibilities:

• Assist in collecting and processing adverse event information.
• Review drug safety reports for accuracy and completeness.
• Support data entry into pharmacovigilance databases.
• Assist in preparing Individual Case Safety Reports (ICSRs).
• Maintain drug safety records and case processing trackers.
• Support medical literature screening activities.
• Track safety reporting timelines and documentation.
• Follow company SOPs and applicable pharmacovigilance guidelines.

Skills Required:

• Basic knowledge of pharmacology and drug safety.
• Understanding of adverse event reporting.
• Strong data entry and documentation skills.
• Good analytical and communication skills.
• Proficiency in Microsoft Excel and Word.

Preferred:

• Internship or academic project experience in pharmacovigilance.
• Familiarity with safety databases and ICH guidelines.