Medical Director, Pharmacovigilance - Remote

Overview

The Medical Director of Pharmacovigilance is responsible for strategic leadership and medical oversight of BioMarin's pharmacovigilance activities, focusing on safety risk management throughout the product lifecycle.

In Short

• Remote contract role for a Medical Director in Pharmacovigilance.
• Lead medical review of safety reports and data for BioMarin products.
• Contribute to policies and SOPs for safety information processing.
• Collaborate with cross-functional teams to manage safety signals.
• Participate in drug development safety surveillance and risk management plans.
• Provide medical advice and support for audits.
• Assist in literature review for adverse drug reactions.
• Participate in training and preparation of safety reports.
• Ensure compliance with US and international pharmacovigilance regulations.
• Manage and mentor team members in drug safety.

Requirements

• Medical degree (MD or DO) with experience in pharmacovigilance.
• Minimum 5 years of experience in drug safety operations.
• Excellent medical knowledge and communication skills.
• Experience with safety data review and reporting.
• Strong understanding of US and ex-US pharmacovigilance requirements.
• Knowledge of MedDRA terminology and safety management.
• Proficiency in Word, Excel, and safety databases.
• Managerial experience in a Drug Safety department is desirable.
• Strong organizational and leadership skills.
• Ability to prioritize tasks effectively.

Benefits

• Opportunity to work with a leading biotechnology company.
• Remote work flexibility.
• Engagement in innovative drug development.
• Collaboration with expert teams in genetics and pharmacovigilance.
• Professional growth and development opportunities.