Pharmacovigilance Director (Raleigh, NC; )

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 cross-functional 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, problem-solving, and interpersonal skills.

• Proficiency in pharmacovigilance databases and software.

Department: Direct Clients
This is a full time position