Regulatory Compliance Specialist

1 day ago

Sydney, New South Wales, Australia Lilly Full time

We are seeking a skilled Regulatory Compliance Specialist to join our team in Australia and New Zealand.

Job Overview

The purpose of this role is to ensure compliance with internal and external requirements concerning Pharmacovigilance. This fixed-term 12-month position will cover parental leave.

Key Responsibilities

  • Execute pharmacovigilance activities, including adverse event management, expedited and periodic reporting, risk management, and creation and maintenance of the Pharmacovigilance System Master File.
  • Evaluate national pharmacovigilance legislation and regulation for drugs and devices.
  • Liaise with regulatory authorities and collaborate with legal, quality, medical, and regulatory teams on safety issues.
  • Contribute to local Risk Management Plans and risk minimization activities.
  • Establish and maintain local business alliance and third-party safety agreements.
  • Develop and deliver training programs for employees and business partners on pharmacovigilance awareness.
  • Submit pharmacovigilance documents to national authorities and Ethics Review Board as required.
  • Manage adverse event reports and database reconciliation.
  • Ensure accuracy and completeness of adverse event reports from post-marketing programs and spontaneous sources.
  • Submit case reports to national regulatory authorities.
  • Reconcile case reports with business partners, medical information, and product quality.
  • Maintain inspection and audit readiness and participate in inspections, audits, and assessments.
  • Develop and implement relevant safety standard operating procedures (SOPs).

Selection Criteria

  • Bachelor's degree in a health profession or life science field or equivalent experience in patient safety.
  • Experience working with local, regional, and global procedures.
  • Familiarity with national regulatory guidelines, directives, and regulations in Pharmacovigilance.
  • Excellent communication, interpersonal, organizational, and negotiation skills.
  • Strong knowledge of quality management systems.

This is an exciting opportunity to contribute to the success of Lilly's Pharmacovigilance team. We offer a competitive salary package and benefits, including a base salary of approximately AUD $120,000 per annum, depending on location and experience.

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