About Hugel America
Hugel America is the U.S. affiliate of Hugel, Inc., a global leader in medical aesthetics headquartered in South Korea. As part of Hugels global expansion strategy, Hugel America oversees regional subsidiaries, including Hugel Canada and Hugel Australia, expanding Hugels presence and compliance footprint across North America and Oceania. Hugel America is focused on introducing and growing its innovative portfolio of botulinum toxin, dermal fillers, and other aesthetic portfolio in key global markets.

The Opportunity
We are seeking a highly motivated and self-driven Pharmacovigilance (PV) professional to independently manage PV responsibilities for the U.S., Canada, and Australia as part of Hugel America. This is a standalone role, responsible for executing all local safety activities, ensuring regulatory compliance, and serving as the primary PV contact for regional authorities and partners.

This position is ideal for someone who is confident operating autonomously, thrives in a dynamic and evolving environment, and brings hands-on experience in pharmacovigilance within the pharmaceutical, biologics, or medical aesthetics industry.

Key Responsibilities

Pharmacovigilance Operation

• Independently manage end-to-end PV activities for the U.S., Canada, and Australia, ensuring compliance with local regulatory requirements (e.g., FDA, Health Canada, TGA).
• Oversee the intake, documentation, and timely submission of Individual Case Safety Reports (ICSRs), including follow-up activities and reconciliation.
• Ensure timely preparation and submission of aggregate safety reports.
• Maintain up-to-date knowledge of regional PV regulations and proactively communicate changes to global PV and relevant stakeholders.

3rd party Agency & Process Management

• Manage local PV related service providers (e.g., QMS system, safety database providers, Medical Information Contact Centers) and ensure service delivery aligns with safety and quality standards.
• Monitor performance metrics and compliance KPIs; implement process improvements where necessary.
• Coordinate with local teams to support literature monitoring, product complaint handling, and medical writing related to safety.

Cross-functional Collaboration & Medical Support

• Collaborate with Regulatory Affairs, Quality, Medical Affairs, and Commercial teams to ensure integrated safety strategies.
• Provide PV input during Promotional Review Committee(PRC) process, internal training sessions, and region-specific commercial or medical activities to ensure compliance with local and global safety requirements.
• Support the development of safety-related communication materials, FAQs, and training documents when needed.

What You Bring

• Education: Bachelors degree in pharmacy, life sciences, nursing, or a related healthcare discipline (required)
• Experience:
  • 37 years of hands-on pharmacovigilance experience, ideally covering multiple regions (U.S., Canada, Australia).
  • Direct experience with ICSR processing, aggregate report preparation, and health authority interactions.
  • Experience working independently in a standalone PV function or within a small team is highly desirable.
• Skills:
  • Deep understanding of regional PV regulations (FDA, Health Canada, TGA) and global safety standards(ICH, GVP, MedDRA coding, etc.).
  • Excellent attention to detail, documentation accuracy, and compliance mindset.
  • Strong communication and collaboration skills for effective cross-functional engagement.
  • Ability to manage multiple priorities and deadlines autonomously in a dynamic regulatory environment..
  • Experience with safety databases, especially Veeva Vault and proficiency in MS Office tools..

• Other:
  • Ability to participate in regional calls across time zones and travel occasionally if needed (e.g., inspections, partner audits).