Associate Director of Clinical Development & Pharmacovigilance - Remote

Overview

The Associate Director of Clinical Development & Pharmacovigilance will provide quality oversight and compliance support for clinical development and pharmacovigilance activities related to biologic development programs, ensuring adherence to global regulatory standards.

In Short

• Provide QA oversight for clinical trials and pharmacovigilance activities.
• Ensure compliance with regulatory standards and guidelines.
• Support audit readiness of clinical trial sites and vendors.
• Monitor adverse event reporting and safety data exchange.
• Collaborate across clinical, pharmacovigilance, and regulatory functions.
• Manage deviations and corrective actions in clinical activities.
• Facilitate training on GCP and GVP policies.
• Participate in vendor qualification and oversight.
• Provide quality input into regulatory submissions.
• Support continuous improvement initiatives in QA functions.

Requirements

• Bachelor’s or advanced degree in Life Sciences or related field.
• Minimum of 10 years in Quality Assurance in Clinical Operations or Pharmacovigilance.
• Strong knowledge of ICH-GCP and FDA regulations.
• Experience with CRO and vendor oversight.
• Familiarity with electronic systems for clinical and safety data.
• Excellent communication and organizational skills.
• Ability to influence and collaborate across functions.

Benefits

• Competitive salary and compensation package.
• Opportunity to work in a dynamic biopharmaceutical environment.
• Collaboration with a diverse team of professionals.
• Focus on innovative treatments for serious metabolic diseases.
• Support for continuous professional development.