Senior Pharmacovigilance Associate

3 weeks ago

Sydney, New South Wales, Australia Johnson & Johnson Full time
About the Role

We are seeking a highly skilled Pharmacovigilance Associate to join our team in Australia and New Zealand. As a key member of our Pharmacovigilance team, you will be responsible for ensuring the safe and effective use of our products in the region.

Key Responsibilities:

  • Collaborate with local operating company (LOC), regional and global affiliates to enable the fulfilment of regulatory responsibilities and meet business objectives.
  • Lead and collaborate with cross-functional teams to develop local Risk Management Plans/Australia-specific annex (ASA) in compliance with local regulations.
  • Assess PV impact of company-sponsored Related Research Activities (RRAs) and conduct training on PV requirements to internal stakeholders and external vendors.
  • Review PV Agreements (PVAs) and other contracts with external vendors.
  • PV regulatory requirements monitoring, review, and implementation.
  • Review and implement Clinical Trials Safety Monitoring Plan.
  • Collaborate and support the case management team.

Requirements:

  • Tertiary qualification in pharmacy, life science or pharmaceutical degree.
  • Pharmacovigilance experience in the pharmaceutical industry.
  • Solid stakeholder management skills and achieving business deliverables.
  • Strong understanding of the Australian and New Zealand pharmacovigilance requirements and global aspects of drug safety.
  • Understanding of Global Medical Safety database systems.
  • Experience in case management and PSP vendor PV compliance oversight, PVA, SMP, and development of RMP/ASA is preferred.

About Us

Johnson & Johnson is a leading global healthcare provider with a long track record in developing and marketing treatments that make a real difference. We are committed to working in partnership with and support Aboriginal and Torres Strait Islander peoples and organisations by recognising and respecting the diversity of cultures, identity, heritage, languages, lores, and social and spiritual systems practiced.

What We Offer

We offer a competitive remuneration package along with continuous training, support and award-winning leadership development programs. As a member of our team, you will have the opportunity to work with a talented and diverse group of professionals who are passionate about making a difference in the lives of patients.

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