Pharmacovigilance Lead, Region APAC

1 week ago

Singapore Novo Nordisk Full time $90,000 - $120,000 per year
About the department

The position
Key responsibilities include, but are not limited to:
  • Create and Lead the APAC PV Leadership team, including affiliate Qualified Person of Pharmacovigilance (QPPV) and safety responsible persons. Coordinate PV compliance activities across the region: Individual Case Safety Report (ICSR), clinical safety reports, PV deviations, audits, inspection trends, and raise awareness.
  • Establish and maintain strong Patient Safety awareness and a robust PV governance system, ensuring PV roles, processes, and responsibilities are anchored in affiliates aligned with local and international requirements.
  • Monitor local PV regulations systematically in affiliates and ensure timely implementation of new or changed PV requirements with proper impact assessment as well as Provide Global Patient Safety (GPS) timely feedback on major PV requirement changes or challenges and support collaboration.
  • Implement a proactive compliance approach through regular review and trending of PV deviations, ICSR compliance, audit and inspection findings, and PV resource issues. Also, conduct face-to-face mock PV audits at APAC affiliates to verify compliance and determine challenges and mitigation strategies.
  • Serve as subject matter expert on PV requirements and customer engagement programs as well as support customer engagement projects related to third-party partners, including assessments, due diligence, and training. Collaborate with QA to qualify external PV partners and conduct audits. Support risk management program (RMP) design and localization. Ensure timely PV training and onboarding and provide PV inputs for the regional QMR (Quality Management Review) process.
Qualifications
  • University degree in Pharmacy, Medicine, or related scientific educational background.
  • Over 7 years of experience in Pharmacovigilance, with solid experience working in international teams and demonstrated leadership.
  • Strong leadership and business acumen, showing agility and fast solution orientation, with strong stakeholder management, cross-functional collaboration and communication with impact.
  • Experience leading teams without direct reporting lines, able to create and drive strategy.
  • Solution-oriented, responsible, detail-focused, proactive, able to navigate diverse setups easily, self-motivated, with an independent working style; advanced English language skills.
Contact
Deadline

Novo Nordisk

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