Senior Pharmacovigilance Manager

GALDERMA AUSTRALIA

Base: $160,000-$200,000; bonus/equity: annual shor...
Hybrid
8+ years pharmacovigilance experience
Fda and ich regulatory knowledge
Signal detection and risk management
Galderma Australia is seeking a Senior Pharmacovigilance Manager to oversee and enhance their local pharmacovigilance system while ensuring compliance with regulatory standards. The ideal candidate will have extensive experience in pharmacovigilance, along with strong leadership and communication skills, to effectively manage safety operations and collaborate with cross-functional teams

Job Summary

  • This senior leadership role provides strategic and operational oversight of the local pharmacovigilance system while serving as the designated Deputy Local Safety Officer.
  • The position requires leading day-to-day PV operations including safety surveillance, signal detection, risk management, and periodic reporting to ensure full regulatory compliance.
  • Candidates will benefit from a competitive base salary range of $160,000-$200,000, an annual short-term incentive program, and comprehensive benefits including health insurance and a 401(k) match.

Matching Summary

Match Score: 85

Galderma Australia is seeking a Senior Pharmacovigilance Manager to oversee and enhance their local pharmacovigilance system while ensuring compliance with regulatory standards. The ideal candidate will have extensive experience in pharmacovigilance, along with strong leadership and communication skills, to effectively manage safety operations and collaborate with cross-functional teams.

Salary

Base: $160,000-$200,000; Bonus/Equity: Annual short-term incentive program based on corporate and individual performance; Benefits: Health insurance, 401(k) plan with employer match, generous paid time off, hybrid work schedules

Skills & Requirements

Must-have

  • 8+ years pharmacovigilance experience
  • FDA and ICH regulatory knowledge
  • Signal detection and risk management
  • Periodic safety reporting (PSUR/PBRER)
  • Vendor governance and oversight
  • Inspection readiness strategy
  • Team leadership and mentoring

Nice-to-have

  • ISoP or DIA certification preferred
  • Experience with patient support programs
  • Matrix organization navigation skills
  • Strong stakeholder influencing capabilities
  • Positive energy and collaborative mindset

Key Requirements

  • Advanced degree in life sciences, pharmacy, medicine, or related discipline
  • 8+ years progressive experience in pharmaceutical or biotechnology PV
  • Demonstrated experience leading local PV operations and regulatory inspections
  • In-depth knowledge of FDA requirements, ICH guidelines, and EU GVP modules
  • Proven people leadership experience including mentoring and performance management

Work Rights

Not specified

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