What are the responsibilities and job description for the Pharmacovigilance Director (Raleigh, NC; ) position at CEDENT?
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
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Design and implement pharmacovigilance and safety strategies across the product portfolio.
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Lead internal and external presentations on complex safety topics.
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Oversee the clinical evaluation of adverse event (AE) reports, including causality assessments and severity analysis.
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Develop and oversee risk management and mitigation plans.
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Maintain and update the pharmacovigilance database.
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Ensure compliance with international pharmacovigilance regulations.
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Oversee preparation and submission of safety narratives, case reports, and regulatory documents such as PSURs.
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Collaborate with cross-functional teams to complete corrective and preventive actions and ensure patient safety.
Requirements
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Medical degree (MD) with a valid US medical license.
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Additional certification in pharmacovigilance or drug safety preferred.
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Minimum of 5 years of experience in pharmacovigilance or a related field.
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Comprehensive knowledge of pharmacovigilance regulations (e.g., FDA, EMA, ICH).
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Strong analytical, problem-solving, and interpersonal skills.
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Proficiency in pharmacovigilance databases and software.
Department: Direct Clients
This is a full time position
