Pharmacovigilance Director

4 weeks ago


Morrisville, United States Cedent Consulting Inc Full time

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)





  • Morrisville, United States Cedent Consulting Inc Full time

    SummaryThe 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...