Instagram
youtube
Facebook

Associate Director, Pharmacovigilance

8+ years
Not Disclosed
10 Dec. 24, 2024
Job Description
Job Type: Full Time Education: MD/DO 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

Job Title: Associate Director of Pharmacovigilance
Location: Not specified (likely field-based or company headquarters)
Company: Not specified

Job Overview:

The Associate Director of Pharmacovigilance will be responsible for providing expert leadership in pharmacovigilance (PV) by reviewing and assessing safety information from various sources. This includes evaluating medical content, identifying potential safety signals, and leading safety activities and benefit-risk assessments. The role also involves chairing Safety Surveillance Committees, contributing to Independent Data and Safety Monitoring Committees (DSMCs), and providing medical expertise throughout the product lifecycle.

Qualifications:

  • Education:
    • MD or equivalent required.
    • Postgraduate qualification or experience in gene therapy, cell therapy clinical development, or a related specialty is preferred.
  • Experience:
    • At least 8 years of experience in pharmacovigilance.
    • In-depth knowledge of pharmacovigilance processes with the ability to assess safety concerns and minimize patient risk throughout the product lifecycle.
    • Experience in cardiovascular or rare disease therapeutics is highly desirable.

Key Responsibilities:

  • Safety Leadership:
    • Lead safety activities and develop benefit-risk strategies for assigned programs.
    • Chair Safety Surveillance Committees for assigned programs and contribute to DSMC meetings for investigational products.
  • Safety Review and Reporting:
    • Provide medical input in the preparation and review of aggregate safety reports (e.g., PBRER, DSUR, 120-day safety updates).
    • Review safety sections of clinical trial documents (e.g., protocols, clinical study reports, investigator brochures, informed consent forms).
    • Contribute to regulatory submissions (e.g., clinical trial applications, marketing authorization applications).
  • Medical Expertise:
    • Serve as the medical expert in safety for assigned programs.
    • Prepare responses to safety-related queries from regulatory authorities as needed.

Desired Skills and Attributes:

  • Strong leadership and communication skills to work cross-functionally with clinical development teams, regulatory affairs, and other stakeholders.
  • Ability to independently manage and review pharmacovigilance activities and provide strategic oversight.
  • High level of attention to detail with experience in evaluating safety data at both individual and aggregate levels.

This position offers the opportunity to play a pivotal role in shaping the safety profile of investigational and marketed products within a specialized field.