Head of Drug Safety and Pharmacovigilance

Department/Group: Drug Safety
Location: Burlingame, CA
Position Type: Full time

Job Description

Role and Responsibilities

  • Sets vision and direction through resource allocation decisions for the drug safety and pharmacovigilance department
  • Manages and oversees the company’s drug safety and pharmacovigilance process
  • Manages compliance with standard operating procedures, regulatory safety and pharmacovigilance in compliance with national and international regulations, such as the Food and Drug Administration (FDA) and World Health Organization, global, regional and country regulations for the reporting of adverse events to regulatory agencies
  • Coordinates the development of guidelines and ensures the uniform and timely processing of adverse event reports
  • Interfaces with internal and external collaborators to develop programs, meetings and processes to meet regulatory reporting requirements
  • Oversees the development and preparation of reports for company management as well as external regulatory agencies
  • Manages and conducts ongoing safety surveillance on company products
  • Oversees the preparation of new drug application safety updates, investigational new drug safety reports, protocols, investigator communications, product labeling/package inserts and other reports as necessary
  • Participates in oversight of ongoing clinical trials and in the preparation of new drug applications with respect to drug safety
  • Attend external conferences for continued education and proficiency on content and processes related to Pharmacovigilance and Drug Safety
  • Develops and implements strategic plans and objectives for the organization in alignment with corporate strategy
  • Oversees direction and approves tactical administrative or operational policies and resource allocation decisions to ensure achievement of corporate objectives
  • Develops strategic plans to ensure successful implementation of action plans and objectives where analysis of situations or data requires an in-depth knowledge of the company, competitive environment, technology and economic or social implications of organization activities
  • Participates in the development of corporate methods, techniques and evaluation criteria for projects, programs and people
  • Approves budgets and schedules to meet corporate requirements
  • Interacts with internal and external industry leaders regarding highly visible projects and activities, while influencing or negotiating matters of great significance on behalf of the company
  • Has overall control of planning, staffing, budgeting, managing expense priorities, and approving changes to methods and practices
  • Manages a team of individual contributors in pharmacovigilance

Qualifications and Education Requirements

  • MD degree or relevant PhD degree required
  • 12+ years of related experience in pharmacovigilance preferably in oncology required

Preferred Skills

  • Excellent teamwork, leadership and collaboration skills
  • Able to build effective working relationships throughout the organization internally and externally to achieve goals.
  • Flexibility and willingness to solve problems that fall outside of immediate area of expertise
  • Clear and concise verbal and written communication skills and strong organizational skills, with an exceptional attention to detail.
  • Work independently in an interdisciplinary, fast-paced, often changing environment.
  • Committed to the values of integrity, accountability, transparency, and drive.
  • Proficient with Microsoft Office and other relevant programs

Join our Team

Local candidates only please! If you are interested, please submit a cover letter and your resume to careers@corvuspharma.com