QPPV & Pharmacovigilance (PV) Associate/Manager

2 weeks ago

Sydney, New South Wales, Australia Cipla Australia Pty Ltd Full time $90,000 - $120,000 per year

Award-Winning Workplace: Proudly GPTW Certified, fostering a culture of collaboration and excellence.

Grow with Us: As Cipla expands, so do opportunities for our team.

Competitive Rewards: Attractive salary, benefits, and incentives that recognise your success.

About Cipla

Caring for Life - At Cipla, care is at the heart of everything we do. With a presence in 80+ countries and a portfolio of over 1,500 products, we are committed to making high-quality healthcare accessible and affordable. As a global leader, we focus on key markets including India, South Africa, and the U.S., driving innovation across various therapeutic areas.

About the role

In this role, you will act as the Australian Pharmacovigilance (QPPV) person, ensuring Cipla maintains a robust and compliant PV system. You will oversee safety reporting, risk management, and PV communications with both internal and external stakeholders, while driving compliance with TGA requirements and ensuring ongoing inspection readiness.

Responsibilities

Compliance & Inspection Readiness

  • Act as the Australian Pharmacovigilance (PV) contact for the TGA.
  • Ensure compliance with all PV regulations and maintain inspection readiness.
  • Support audits with business partners.

System Oversight

  • Oversee reporting of adverse events, periodic safety updates, and safety submissions.
  • Ensure PV procedures and quality systems are clearly defined and up to date.
  • Keep global teams informed of local safety updates and regulatory actions.

Stakeholder Engagement

  • Serve as the main point of contact for PV communications with the TGA, Cipla global teams, and business partners.
  • Coordinate activities related to product recalls, complaints, and safety agreements.

Risk & Safety Management

  • Manage the submission of safety issues and risk management plans.
  • Provide oversight of post-marketing safety programs in Australia.
  • Monitor and investigate safety reports to ensure patient protection.

Medical Information

  • Oversee medical information systems for Australia.
  • Collaborate with global teams on PV and medical information matters.
  • Share updates on Australian regulatory requirements with wider stakeholders.

Educational Qualifications

Degree in Life Sciences (or equivalent).

Relevant Experience

Minimum 5+ years in pharmacovigilance or drug safety, with direct exposure to TGA requirements and PV system oversight.

If you're ready to take a leading role in patient safety and pharmacovigilance, and grow your career with Cipla, we'd love to hear from you. Apply now and help make a lasting difference in healthcare.

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