Pharmacovigilance Director Job at CEDENT, Raleigh, NC

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  • CEDENT
  • Raleigh, NC

Job Description

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.

Job Tags

Full time,

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