Associate Director of Pharmacovigilance Operations - Remote

Overview

The Associate Director of PV Operations will oversee pharmacovigilance activities related to expanded and early access programs, ensuring compliance and effective communication across teams.

In Short

• Oversee EAP vendor and safety data exchange agreements.
• Reconcile adverse events between databases.
• Ensure safety reporting compliance for EAP countries.
• Act as primary contact for PV requests within EAPs.
• Support regulatory inspections and PV operations.
• Identify risks and opportunities within EAPs.
• Collaborate with internal and external stakeholders.
• Maintain excellent communication and decision-making skills.
• Manage relationships with service providers.
• Contribute to the expansion of PV operations.

Requirements

• Bachelor’s degree in a relevant field.
• 8+ years of experience in biotechnology or pharmaceuticals.
• 4+ years in Pharmacovigilance operations.
• Expert knowledge of Argus or equivalent PV database.
• Ability to interpret regulatory guidelines.
• Knowledge of Good Documentation Practices and cGXPs.
• Experience in ICSR case-processing and reporting.
• Strong knowledge of regulatory requirements (EMA, FDA, ICH).
• Expertise in pharmacovigilance activities.
• Experience managing external business relationships.

Benefits

• Equal employment opportunities.
• Collaborative work environment.
• Opportunity to work with experienced professionals.
• Involvement in innovative drug development.
• Potential for career growth within the company.