Senior Medical Director, Drug Safety and Pharmacovigilance, International - Remote

Overview

The Senior Medical Director is responsible for leading the international safety strategy for assigned products, overseeing core safety information, and collaborating with various departments to ensure compliance and safety in drug development and post-marketing phases.

In Short

• Lead the international safety strategy for assigned products.
• Oversee core safety information and local labeling.
• Conduct benefit-risk assessments and risk management.
• Manage medical adverse event data and aggregate safety data.
• Collaborate with Clinical Operations, QA, and Regulatory Affairs.
• Engage with Regulatory Authorities during inspections.
• Ensure compliance with pharmacovigilance regulations.
• Conduct safety audits across international partner organizations.
• Develop and present assessments of safety data.
• Participate in publication preparation and medical information reviews.

Requirements

• Medical Degree with at least 12 years of drug safety experience.
• Experience with regulatory submissions and inspections.
• Knowledge of GCP and FDA/EMA regulations.
• Proven ability to manage drug safety teams.
• Experience with safety signal evaluation and data analysis.
• Strong collaboration skills with cross-functional teams.
• Ability to travel periodically for meetings with regulatory authorities.
• Familiarity with safety databases and reporting tools.
• Experience in managing compliance deviations.
• Strong communication and presentation skills.

Benefits

• Access to learning and development resources.
• Robust compensation and benefits package.
• A collaborative and fast-paced work environment.
• Commitment to Diversity, Equity & Inclusion.
• Patient Days to engage with individuals impacted by conditions.