Associate Director, Pharmacovigilance

2 months ago

Sydney, Australia Lilly Full time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

**JOB SUMMARY**

The purpose of the Associate Director of North Asia-Pacific (NAPAC) Pharmacovigilance role is to provide leadership and people management for the employees in affiliate pharmacovigilance roles across the NAPAC Hub (Korea, Taiwan, Hong Kong, Macau, Australia and New Zealand) to ensure quality and compliance in pharmacovigilance operations, collaborate with internal and external stakeholders; ensure continuous improvements of processes and implementations of processes and relevant regulations into safety system through comprehensive business and technical knowledge/experience. The Associate Director - NAPAC Pharmacovigilance serves as a link between Global Patient Safety (GPS) and the affiliate safety teams.

**JOB RESPONSIBILITIES**

**1. General Responsibilities and Regulatory Compliance**:

- Responsible for the establishment and maintenance of Lilly’s local pharmacovigilance (PhV) 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 NAPAC Hub.
- Provide strategic direction for the execution of pharmacovigilance activities (e.g. adverse event management, expedited and periodic reporting, risk management and creation and maintenance of the Pharmacovigilance System Master File).
- Evaluate any safety and compliance issues with global management and facilitate execution of corrective and preventive action plan as needed.
- Acts as an interface between Global Patient Safety (GPS) and NAPAC safety personnel
- Responsible for appropriate communications between patient safety locally and other stakeholders, GPS, product complaints, medical and regulatory affairs, European Qualified Person for Pharmacovigilance (QPPV), product quality, clinical operations, legal, ethics and compliance and commercial partners.
- Manage regional communication network; lead regular meetings with NAPAC safety personnel, serve as a key resource for pharmacovigilance within NAPAC.
- Provide technical expertise to the aligned affiliate and GPS with respect to the interpretation and implementation of relevant 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.
- Review metrics to monitor quality and compliance activities and implement any corrective and or preventative actions.
- Support review of any local business agreements that require safety and regulatory input (e.g. business alliances, patient support programs, distribution agreements) and ensure required agreements with respect to PhV are in place, up to date and followed as required.
- Define strategies and lead response to complex technical issues for specific safety aspects in relation to projects, and various activities.
- Support negotiations with health authorities and the review of responses to regulatory agency requests, queries, PSURs and RMPs and local risk minimization tools as needed.
- Establish and ensure continuous improvement of global, regional, and local PhV procedures and quality culture.
- Responsible for optimizing the value of Lilly products through the promotion of patient safety.
- Establish key relationships within the industry network to gather relevant information that might influence the safety activities and leverage gathered knowledge to improve patient safety.
- Contribute for policy making activities through identifying and establishing relationship with (such as foundation of pharmacovigilance) key opinion leaders**.**

**2. People Management**:

- Recruit, train**,** and develop skilled individuals that are motivated to work with a high-quality standard and achieve department and company objectives.
- Ensure completion of employee performance objectives and development plans through annual employee performance evaluations
- Implement performance management, career management and succession planning to maximize career potential, retain talented people for the long term and maximize value to the corporation.

**3. Standards and Inspection Readiness**
- Coordinate and strive for inspection and audit readiness and participate in affiliate inspections, audits, and as

  • Associate Director, Pharmacovigilance Lead

    1 month ago

    Sydney, New South Wales, Australia Eli Lilly Full time

    Job SummaryThe Associate Director of North Asia-Pacific (NAPAC) Pharmacovigilance role is a critical leadership position that oversees the pharmacovigilance operations across the NAPAC Hub. The successful candidate will provide strategic direction and people management to ensure quality and compliance in pharmacovigilance activities, collaborate with...

  • Pharmacovigilance Manager

    1 month ago

    Sydney, Australia Lilly Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Pharmacovigilance Director

    4 weeks ago

    Sydney, New South Wales, Australia Eli Lilly Full time

    Job Title: Pharmacovigilance ManagerLilly is a global healthcare leader seeking a highly skilled Pharmacovigilance Manager to join our team. As a key member of our Pharmacovigilance department, you will be responsible for providing leadership and people management for employees in affiliate pharmacovigilance roles.Key Responsibilities:Fulfill legal and...

  • Pharmacovigilance Director

    1 month ago

    Sydney, New South Wales, Australia Eli Lilly Full time

    Job Title: Pharmacovigilance ManagerLilly 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...

  • 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 at Johnson & Johnson. As a key member of our safety team, you will be responsible for ensuring the safe use of our products and contributing to the development of innovative solutions to improve patient outcomes.Key ResponsibilitiesCollaborate with cross-functional...

  • Senior Pharmacovigilance Associate

    2 months ago

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

    About the RoleWe are seeking a highly skilled Pharmacovigilance Associate to join our team at Johnson & Johnson. As a key member of our safety team, you will be responsible for ensuring the safe use of our products and contributing to the development of innovative healthcare solutions.Key ResponsibilitiesCollaborate with cross-functional teams to develop and...

  • Senior Pharmacovigilance Associate

    2 months ago

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

    About the RoleWe are seeking a highly skilled Pharmacovigilance Associate to join our team at Johnson & Johnson. As a key member of our safety team, you will be responsible for ensuring the safe use of our products and contributing to the development of innovative healthcare solutions.Key ResponsibilitiesCollaborate with cross-functional teams to develop and...

  • Senior Pharmacovigilance Associate

    2 months ago

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

    About the RoleWe are seeking a highly skilled Pharmacovigilance Associate to join our team at Johnson & Johnson. As a key member of our safety team, you will be responsible for ensuring the safe use of our products and collaborating with cross-functional teams to develop and implement risk management plans.Key ResponsibilitiesCollaborate with local operating...

  • Pharmacovigilance Specialist

    1 month ago

    Sydney, New South Wales, Australia Lilly Full time

    Job Title: Pharmacovigilance AssociateWe're seeking a highly skilled and dedicated individual to join our team as a Pharmacovigilance Associate. This is a fixed-term 12-month parental leave cover role, providing an excellent opportunity to gain valuable experience in the field of pharmacovigilance.Key Responsibilities:Execute pharmacovigilance activities,...

  • Senior Pharmacovigilance Associate

    2 months ago

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

    About the RoleWe are seeking a highly skilled Pharmacovigilance Associate to join our team at Johnson & Johnson. As a key member of our safety team, you will be responsible for ensuring the safe use of our products and collaborating with cross-functional teams to develop and implement risk management plans.Key ResponsibilitiesCollaborate with local operating...

  • Pharmacovigilance Specialist

    4 days 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...

  • Drug Safety Associate

    4 weeks ago

    Sydney, New South Wales, Australia Viatris Full time

    Viatris is a global healthcare company that empowers people to live healthier at every stage of life. We are seeking a highly skilled Drug Safety Associate to join our Pharmacovigilance team.Key Responsibilities:Support the management of all pharmacovigilance activities, including collection, review, follow-up, and reporting of adverse events in accordance...

  • Lead Pharmacovigilance Specialist

    2 months ago

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

    Exciting Career Opportunity at Johnson & JohnsonJohnson & Johnson is a premier healthcare organization dedicated to advancing innovative solutions that enhance patient care. We are currently in search of a dedicated professional to join our ranks as a Senior Pharmacovigilance Associate in the Australia and New Zealand region.Key Responsibilities:Engage with...

  • Senior Pharmacovigilance Professional

    1 week 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...

  • Senior Pharmacovigilance Associate

    3 weeks 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...

  • Local Pharmacovigilance Qualified Person

    2 months ago

    Sydney, Australia IQVIA Full time

    **Essential Functions** - Act as the LQPPV in accordance with requirements set out in IQVIATM Lifecycle Safety Regulatory Intelligence Database (RID). - Availability on a 24/7 basis to receive calls from the local Competent Authority as required. Act as the contact point for pharmacovigilance inspections. Deal directly with the Competent Authority inspectors...

  • Pharmacovigilance Associate

    5 months ago

    Sydney, Australia Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. PURPOSE: The purpose of the role is to ensure compliance with internal and external requirements concerning Pharmacovigilance in Australia and New Zealand. This role is a fixed-term 12 month parental leave cover. KEY RESPONSIBILITIES: Execute...

  • Drug Safety Associate

    4 weeks ago

    Sydney, New South Wales, Australia Viatris Full time

    Join Our Team as a Drug Safety AssociateViatris is a global healthcare company that empowers people worldwide to live healthier at every stage of life. We are seeking a highly skilled Drug Safety Associate to join our team in Australia.About the Role:The Drug Safety Associate will play a critical role in supporting the management of all pharmacovigilance...

  • Drug Safety Associate

    1 month ago

    Sydney, New South Wales, Australia Viatris Full time

    Join Viatris as a Drug Safety AssociateViatris is a global healthcare company that empowers people worldwide to live healthier at every stage of life. We are seeking a highly skilled Drug Safety Associate to join our team in Australia.About the RoleThe Drug Safety Associate will play a critical role in supporting the management of all pharmacovigilance...

  • Drug Safety Associate

    1 month ago

    Sydney, New South Wales, Australia Viatris Full time

    Join Viatris as a Drug Safety AssociateViatris is a global healthcare company that empowers people worldwide to live healthier at every stage of life. We are seeking a highly skilled Drug Safety Associate to join our team in Australia.Key Responsibilities:Support the management of pharmacovigilance activities, including collection, review, and reporting of...