Pharmacovigilance Director

1 month ago

Sydney, New South Wales, Australia Eli Lilly Full time
Job Title: Pharmacovigilance Manager

Lilly is a global healthcare leader seeking a highly skilled Pharmacovigilance Manager to join our team. As a key member of our pharmacovigilance team, you will be responsible for providing leadership and people management for employees in affiliate pharmacovigilance roles across aligned affiliates.

Key Responsibilities:
  • Fulfill legal and regulatory requirements for the QPPV responsible for pharmacovigilance role as defined by legislation and/or guidelines in the respective country(ies) of the region.
  • Establish and maintain Lilly's local pharmacovigilance system, including the performance of the quality system and pharmacovigilance activities to promote, maintain and improve compliance with the legal requirements and relevant Good Vigilance Practice (GVP) requirements in the region.
  • Understand pharmacovigilance activities (such as: adverse event management, expedited and periodic reporting, risk management and creation and maintenance of the Pharmacovigilance System Master File).
  • Understand the role of the European Qualified Person for Pharmacovigilance (EU QPPV).
  • Escalate any safety and compliance issues to appropriate local and global management.
  • Act as an interface between Global Patient Safety (GPS) and the aligned affiliate.
  • Provide technical expertise to the aligned affiliate and GPS with respect to the interpretation and implementation of national pharmacovigilance legislation/regulation for both drugs and devices.
  • Ensure continuity of adverse event (AE) reporting by coordinating back-up personnel during vacation for Pharmacovigilance activities.
  • Ensure relevant stakeholders are made aware of actions initiated for safety reasons for any Lilly product.
  • Lead, coordinate and organize all necessary training on adverse reporting to the aligned affiliate as appropriate.
  • Review metrics to monitor quality and compliance activities and implement any corrective and or preventative actions.
  • Responsible for the review and approval of any local business agreements that require safety and regulatory input (such as: business alliances, patient support programs, distribution agreements).
  • Collaborate with external customers and be an active participant of the local pharmacovigilance industry association groups.
Requirements:
  • Relevant scientific degree or Bachelor's degree (or higher) in physical or biological sciences required or equivalent demonstrated experience is required.
  • Knowledge and understanding of local, regional and global procedures as applicable.
  • Knowledge of legislation with regards to relevant national regulatory guidelines, directives and regulations in Pharmacovigilance.
Preferred Qualifications:
  • Excellent communication (written and verbal), interpersonal, organizational and negotiation skills.
  • Professional knowledge of English including medical terminology.
  • Strong knowledge of quality systems.

Lilly is an equal opportunity employer and welcomes applications from diverse candidates. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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