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Pharmaceutical Compliance Expert

2 weeks ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $100,000 - $120,000

Job Summary

A Pharmaceutical Compliance Expert is required to support the maintenance of systems and processes that ensure compliance with local regulations.

Main Responsibilities:

  • Collaborate with internal teams to support system maintenance, ensuring adherence to regulatory requirements.
  • Provide functional support for pharmacovigilance activities.
  • Implement strategies to maintain compliance with local regulations.
  • Support in maintaining PV systems, including commercial team engagements and supplier management.
  • Assist in preparing training materials and implementing training programs for sales representatives and others.
  • Work with stakeholders to oversee vendors and ensure quality and timely completion of activities.
  • Contribute to the preparation and submission of safety documents if applicable.
  • Support the implementation of global, regional, and local PV strategies.
  • Support internal and external audits or inspections.
  • Manage suppliers and establish oversight.
  • Maintain contact information for global communications.

Required Skills and Qualifications:

  • Bachelor's degree in life sciences, pharmacy, nursing, or medicine. An advanced degree is preferred.
  • At least 2 years of experience in PV in the pharmaceutical or CRO industry, with understanding of pharmacovigilance and local regulatory requirements.
  • Understanding of medical/scientific terminology.
  • Excellent written/oral communication skills and experience working with stakeholders.
  • Accuracy, attention to detail, and flexibility.
  • Team worker with a collaborative approach.
  • Ability to prioritize tasks under pressure.
  • Well-developed organizational skills and computer literacy.