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Pharmacovigilance Director

5+ years
Not Disclosed
10 Nov. 5, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Summary:

The Director of Pharmacovigilance is a key medical and analytical leader responsible for the safety surveillance of investigational and/or marketed products. This role involves designing and implementing safety strategies, evaluating adverse event (AE) reports, conducting risk assessments, and collaborating with both internal and external stakeholders to ensure compliance with regulatory standards and prioritize patient safety.


Responsibilities:

  • Design and implement pharmacovigilance and safety strategies across the entire product portfolio.
  • Lead internal and external presentations on complex safety-related topics.
  • Oversee the clinical evaluation of adverse event (AE) reports, including conducting causality assessments and severity analysis.
  • Develop and manage risk management and mitigation plans to ensure product safety.
  • Maintain, update, and manage the pharmacovigilance database for comprehensive reporting.
  • Ensure adherence to international pharmacovigilance regulations (FDA, EMA, ICH, etc.).
  • Oversee the preparation and submission of safety narratives, case reports, and regulatory documents, including Periodic Safety Update Reports (PSURs).
  • Collaborate with cross-functional teams to implement corrective and preventive actions related to patient safety.

Requirements:

  • Education: Medical degree (MD) with a valid US medical license.
  • Certification: Additional certification in pharmacovigilance or drug safety is preferred.
  • Experience: Minimum of 5+ years of experience in pharmacovigilance or a related field.
  • Knowledge: Comprehensive knowledge of pharmacovigilance regulations (e.g., FDA, EMA, ICH).
  • Skills: Strong analytical, problem-solving, and interpersonal skills, with proficiency in pharmacovigilance databases and safety software tools.