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.
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