Pharmacovigilance Director

Summary
The Director of Pharmacovigilance (MD) serves as a key medical and analytical leader responsible for the safety surveillance of investigational and/or marketed products. This role involves designing safety programs evaluating adverse event reports and collaborating with internal and external stakeholders to ensure compliance and patient safety.

Responsibilities

• Design and implement pharmacovigilance and safety strategies across the product portfolio.
  

• Lead internal and external presentations on complex safety topics.
  

• Oversee the clinical evaluation of adverse event (AE) reports including causality assessments and severity analysis.
  

• Develop and oversee risk management and mitigation plans.
  

• Maintain and update the pharmacovigilance database.
  

• Ensure compliance with international pharmacovigilance regulations.
  

• Oversee preparation and submission of safety narratives case reports and regulatory documents such as PSURs.
  

• Collaborate with crossfunctional teams to complete corrective and preventive actions and ensure patient safety.
  

Requirements

• Medical degree (MD) with a valid US medical license.
  

• Additional certification in pharmacovigilance or drug safety preferred.
  

• Minimum of 5 years of experience in pharmacovigilance or a related field.
  

• Comprehensive knowledge of pharmacovigilance regulations (e.g. FDA EMA ICH).
  

• Strong analytical problemsolving and interpersonal skills.
  

• Proficiency in pharmacovigilance databases and software.
  

(Remote work option available)