Careers

Title: Director, Pharmacovigilance

Location: Waltham, MA

This position will report to the head of Regulatory and will be responsible for the leadership and co-ordination of pharmacovigilance activities. The Director of Pharmacovigilance will lead the review of safety data and related documents for potential safety issues and supports the medical component of pharmacovigilance activities including: surveillance activities providing scientific/clinical PV expertise with a focus on the identification, evaluation and management of safety risks. You will collaborate closely with cross-functional partners to evaluate and actively manage risks in accordance with global regulatory frameworks.

  • Create and maintain an effective signal tracking process that fully documents signaling activities and can be used for regulatory inspection
  • Provide oversight for the safety data analysis
  • Author/provide strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA)
  • Lead and provide safety expertise to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports
  • Provide oversight to CROs and other PV vendors with day-to-day operational activities for investigational products
  • Evaluate medical coding of safety data
  • Contribute to health authority and other safety-related query responses
  • Support study teams for investigational products; serve as PV expert and liaise with Clinical Operations, Medical Affairs,
  • Demonstrate knowledge and ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.)
  • Prepares aggregate safety reports (e.g. DSURs, PSURs), including project management, safety database requests, understanding and writing the content, assimilating information from other groups, and quality checks
  • Plan and execute literature surveillance
  • Provide leadership in the development, implementation, and maintenance of robust procedures for the planning, preparation, and submission of high-quality safety reports
  • Ensure compliance with Risk Management policies and procedures
  • Develop and implement procedural documents, including SOPs, work instructions, forms and templates that support PV and signal detection processes
  • Support additional PV activities as needed

Qualifications

  • PharmD, MD, PhD, MPH, advanced healthcare degree, or equivalent professional experience
  • Minimum 8 years pharmacovigilance or relevant experience, including at least 5 years concentration on aggregate safety report writing
  • Thorough understanding of the drug development process and context applicable to safety surveillance activities
  • Knowledge of MedDRA terminology and its application
  • Excellent written and oral communication skills, strong attention to detail, and high-performance standards for quality
  • Ability to analyze, interpret, and summarize complex clinical and medical literature data
  • Ability to prioritize and complete work in a resourceful, self-sufficient manner while maintaining a strong mentality
  • Displays ability to understand established procedures and communicate those procedures to others
  • Exhibits comprehension of industry practices and regulations for drug development and pharmacovigilance
  • Demonstrates awareness of related medical disciplines and an understanding of general concepts and some experiential detail within those areas
  • Possesses computer skills to support use of electronic systems and development of writing deliverables

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