VP, PV Head
Location: US (remote)
- To lead the department in establishing and improving the pharmacovigilance system in accordance with laws and regulations and to manage the work of team members.
- To participate in budgeting and quoting for pharmacovigilance projects.
- To develop pharmacovigilance project management plans and update them in due course according to changes, and supervise team members to implement them according to the plans.
- To manage conducting safety event reports and case reviews in accordance with national regulations and internal company standards, cooperating and communicating with relevant internal and external departments, and following up on the tracking and investigation of drug safety information.
- To determine generations and submissions of safety report on a regular basis, as well as analysis of drug safety information and evaluation and assessment of its severity and relevance.
- To develop training plans as needed and organize operational training within the department and for related personnel to enhance the pharmacovigilance awareness of team members.
- To in NDA task force team in document preparations and reviews by regulatory agencies.
- Bachelor's degree or above, majoring in clinical medicine, pharmacy, or bioscience related fields.
- Prior experience managing PV in a small company environment is highly preferred.
- At least 8 years of relevant working experience in pharmaceutical companies or CROs; NDA preparation experience is highly preferred.
- Understanding of relevant drug safety regulatory requirements, including Drug Administration Law, Drug Registration and Management Act, GCP, ICH-E2A/E2B/E2D, ICH-GCP, etc.
- Excellent interpersonal communication skills, keen market insight, ability to grasp market dynamics, fluent English speaking skills.
- Honest, proactive, down-to-earth, team player with a strong sense of responsibility.