Pharmacovigilance Associate Director

Job Summary

A company is looking for an Associate Director, Pharmacovigilance.

Key Responsibilities

• Ensure compliance with regulatory standards by providing timely and accurate safety data outputs
• Collect, analyze, and report adverse event data from clinical trials and post-market surveillance
• Collaborate with cross-functional teams to address quality and compliance-related issues and drive continuous improvement initiatives

Required Qualifications

• Bachelor's degree in Life Sciences; Master's degree is a plus
• 8 - 10 years of experience in drug safety/pharmacovigilance within the pharmaceutical or biotech industry
• Experience with a Pharmacovigilance database, preferably Argus Global safety database
• In-depth knowledge of US and ICH safety reporting regulations and guidelines
• Proficient in MS Word, Excel, and PowerPoint, including statistical analysis