Regulatory Pharmacovigilance Specialist

2 days ago

Sydney, New South Wales, Australia Lilly Full time

**About Lilly

Lilly is a global pharmaceutical leader committed to making life better for people around the world.

The company is looking for highly skilled professionals who can support its mission by ensuring compliance with pharmacovigilance regulations in Australia and New Zealand.

This 12-month parental leave cover position requires an individual with strong knowledge of pharmacovigilance principles and practices, as well as excellent communication and organizational skills.

Job Summary

The Regulatory Pharmacovigilance Specialist will be responsible for executing pharmacovigilance activities, including adverse event management, expedited and periodic reporting, risk management, and creation and maintenance of the Pharmacovigilance System Master File.

The successful candidate will ensure appropriate interpretation and implementation of national pharmacovigilance legislation/regulation for both drugs and devices, and will collaborate with regulatory authorities, legal, quality, medical, and regulatory teams as needed.

Key Responsibilities

  • Execute pharmacovigilance activities as required (e.g. adverse event management, expedited and periodic reporting, risk management, and creation and maintenance of the Pharmacovigilance System Master File).
  • Ensure appropriate interpretation and implementation of national pharmacovigilance legislation/regulation for both drugs and devices.
  • Liaise with regulatory authorities, work with legal, quality, medical, and regulatory teams on safety issues if necessary.
  • Provide input to local Risk Management Plans and local risk minimization activities.
  • Ensure local business alliance and third-party safety agreements are in place, up to date, and followed as required.
  • Provide local training (initial and/or refresher) for employees and/or business alliance partners to raise awareness of pharmacovigilance as required.
  • Submit other pharmacovigilance documents to national authority and Ethics Review Board as required (e.g. periodic reports).
  • Serve as point of contact for reception and collection of Adverse Event reports and manage database.
  • Responsible for accuracy and completeness of adverse event reports from post marketing programs and spontaneous sources for marketed products and devices.
  • Responsible for submission of case reports to national regulatory authorities.
  • Reconciliate case reports with business partners, medical information, and product quality.
  • Strive for inspection and audit readiness and participate in inspections, audits, and assessments.
  • Ensure relevant safety standard operating procedures (SOP) are well understood across the business, lead and provide clarification on local implementation where applicable.
  • Support development of global SOPs to ensure alignment with local laws and regulations.

Selection Criteria

  • Bachelor's degree in a health profession (i.e. Pharmacy, Nursing) or life science field or equivalent demonstrated experience in patient safety.
  • Experience working with local, regional, and global procedures.
  • Knowledge of legislation with regards to relevant national regulatory guidelines, directives, and regulations in Pharmacovigilance. Excellent communication (written and verbal), interpersonal, organizational, and negotiation skills.
  • Strong knowledge of quality management systems.

Benefits

Lilly offers a competitive salary package, ranging between $120,000 - $160,000 AUD per year, depending on experience, plus benefits such as professional development opportunities, flexible working arrangements, and a supportive work environment.

  • Pharmacovigilance Specialist

    4 weeks ago

    Sydney, New South Wales, Australia Lilly Full time

    We're looking for a skilled professional to ensure compliance with internal and external requirements concerning Pharmacovigilance in Australia and New Zealand.Purpose: This fixed-term 12-month parental leave cover role is responsible for executing pharmacovigilance activities as required, ensuring appropriate interpretation and implementation of national...

  • Pharmacovigilance Specialist

    3 weeks ago

    Sydney, New South Wales, Australia Lilly Full time

    About the Role:Lilly is seeking a Pharmacovigilance Associate to ensure compliance with internal and external requirements concerning Pharmacovigilance in Australia and New Zealand.Key Responsibilities:Execute pharmacovigilance activities as required, including adverse event management and expedited and periodic reporting.Ensure appropriate interpretation...

  • Pharmacovigilance Specialist

    3 weeks ago

    Sydney, New South Wales, Australia Lilly Full time

    We're seeking a dedicated professional to ensure compliance with internal and external Pharmacovigilance requirements.Purpose:The purpose of this role is to ensure compliance with Pharmacovigilance in Australia and New Zealand.This role is a fixed-term 12-month parental leave cover.Key Responsibilities:Execute pharmacovigilance activities as required (e.g.,...

  • Pharmacovigilance Specialist

    4 weeks ago

    Sydney, New South Wales, Australia Lilly Full time

    At Lilly, we're committed to making life better for people around the world.Purpose:This role is responsible for ensuring compliance with internal and external requirements concerning Pharmacovigilance in Australia and New Zealand.This is a 12-month fixed-term parental leave cover.Key Responsibilities:Execute pharmacovigilance activities as required,...

  • Regulatory Compliance Specialist

    1 week 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 OverviewThe 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 ResponsibilitiesExecute pharmacovigilance activities,...

  • Senior Pharmacovigilance Associate

    1 month ago

    Sydney, New South Wales, Australia Johnson & Johnson Full time

    About the RoleWe 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...

  • Pharmacovigilance Leader

    4 weeks ago

    Sydney, New South Wales, Australia Healthcare Professionals Group Full time

    Lead the Pharmacovigilance Department in Australia and New ZealandEnsure compliance with local regulations and maintain drug safety standardsAbout the RoleAs the Pharmacovigilance Manager, you will oversee the operations of the Pharmacovigilance Department in Australia and New Zealand. You will serve as the QPPV, managing safety issues and collaborating with...

  • Global Pharmacovigilance Compliance Specialist

    3 weeks ago

    Sydney, New South Wales, Australia Lilly Full time

    Lilly is a leader in the pharmaceutical industry, and we are seeking a highly skilled Global Pharmacovigilance Compliance Specialist to join our team. Estimated salary: $95,000 - $120,000 per annumAbout LillyWe're a company that's passionate about making life better for people around the world. Our mission is to discover, develop, and deliver innovative...

  • Regulatory Compliance Specialist

    1 week ago

    Sydney, New South Wales, Australia Lilly Full time

    Job DescriptionWe are seeking a highly skilled Regulatory Compliance Specialist to ensure compliance with internal and external requirements concerning Pharmacovigilance in Australia and New Zealand.About the RoleThis is a fixed-term 12-month parental leave cover position, providing an exciting opportunity to make a meaningful contribution to our team.Key...

  • Pharmacovigilance Expert for Australia and New Zealand

    4 days ago

    Sydney, New South Wales, Australia Lilly Full time

    Lilly is 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 play a critical role in ensuring compliance with internal and external requirements concerning Pharmacovigilance in the region.About the Role:We are looking for a motivated and experienced...

  • Pharmacovigilance Specialist

    4 weeks ago

    Sydney, New South Wales, Australia Viatris Full time

    At Viatris, we empower people worldwide to live healthier at every stage of life. We see healthcare not as it is but as it should be, acting courageously to be a source of stability in a world of evolving healthcare needs.Key Responsibilities:Support the management of all pharmacovigilance activities including collection, review, follow-up, and reporting of...

  • Pharmacovigilance Expert for Australia and New Zealand

    2 weeks ago

    Sydney, New South Wales, Australia Johnson & Johnson Full time

    Discover a fulfilling career as a Pharmacovigilance Expert with Johnson & Johnson in Australia and New Zealand. Our team is dedicated to delivering high-quality pharmacovigilance services that prioritize patient safety and compliance with regulatory requirements.About the RoleWe are seeking an experienced Pharmacovigilance Expert to join our Country Safety...

  • Senior Pharmacovigilance Professional

    4 weeks ago

    Sydney, New South Wales, Australia Johnson & Johnson Full time

    About the Role:As a Senior Pharmacovigilance Associate at Janssen, you will play a critical role in shaping and executing pharmacovigilance activities for Australia and New Zealand. Your responsibilities will include ensuring compliance with local regulations and company policies/procedures, as well as collaborating with cross-functional teams to develop...

  • Medical Safety Specialist

    2 weeks ago

    Sydney, New South Wales, Australia Lilly Full time

    Lilly is committed to improving people's lives through the discovery, development and delivery of innovative medicines. We are currently seeking a Medical Safety Specialist to join our team.Estimated Salary: $120,000 - $180,000 per yearAbout the Role:We're looking for someone who is determined to make life better for people around the world by ensuring...

  • Regulatory Specialist

    4 weeks ago

    Sydney, New South Wales, Australia Corrs Chambers Westgarth Full time

    We are seeking a talented regulatory specialist to join our Investigations and Inquiries team in Sydney. The ideal candidate will have +4 years PQE and experience of AML/CTF legislation in Australia.As a regulatory specialist, you will work across the full regulatory lifecycle, from regulatory advice to strategy, compliance, enforcement and remediation...

  • Regulatory Specialist

    2 weeks ago

    Sydney, New South Wales, Australia ASIC Full time

    About the RoleASIC is seeking an experienced Regulatory Specialist to join our team. This role offers a unique opportunity to make a real impact in shaping Australia's financial services landscape.SalaryThe salary for this position is estimated at $123,444 per annum, plus 15.4% superannuation.Job DescriptionAs a Regulatory Specialist, you will be responsible...

  • Regulatory Reporting Specialist

    1 month ago

    Sydney, New South Wales, Australia Macquarie Full time

    About the RoleMacquarie is seeking a highly skilled Regulatory Reporting Specialist to join our Commodities and Global Markets Finance team. As a key member of our team, you will play a critical role in ensuring the integrity and accuracy of our regulatory reporting to APRA and other regulatory bodies.In this role, you will be responsible for preparing and...

  • Regulatory Compliance Specialist

    1 month ago

    Sydney, New South Wales, Australia Gaming Laboratories International Full time

    Regulatory Compliance SpecialistSydney, AustraliaGaming Laboratories International (GLI) is seeking a Regulatory Compliance Specialist to join our global Client Services team based out of our Western Sydney office.Key Responsibilities:Provides customer service and support to regulators in the Asia Pacific (APAC) region.Identifies strategic technical and...

  • Regulatory Reporting Specialist

    2 weeks ago

    Sydney, New South Wales, Australia Commonwealth Bank of Australia Full time

    Job SummaryWe are seeking a highly skilled Regulatory Reporting Specialist to join our team at the Commonwealth Bank of Australia.About the RoleThis is an exciting opportunity to work in a dynamic environment and contribute to the bank's regulatory reporting requirements. As a Regulatory Reporting Specialist, you will be responsible for preparing and...

  • Regulatory Affairs Specialist

    4 weeks ago

    Sydney, New South Wales, Australia Johnson & Johnson Full time

    Regulatory Affairs Specialist Position OverviewJohnson & Johnson is currently seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs team, you will play a critical role in supporting our business growth by providing regulatory leadership of a portfolio of products.Main Responsibilities:Lead a...