Johnson & Johnson Careers

ANZ Cross Sector Safety Lead (Pharmacovigilance)

Sydney, Australia
Medical Affairs


Job Description

Requisition ID: 1805688297W

  • Pharma and Consumer
  • Sydney based, North Ryde
  • Leading company

The Johnson & Johnson Family of Companies; A global leader in health and personal care, with over 125,000 employees in over 275 companies in 60 countries. We work with partners in healthcare to touch the lives of more than a billion people every day throughout the world. Johnson & Johnson companies market leading products and services in three business segments: Consumer, Pharmaceuticals, and Medical Devices.

“By caring, one person at a time, we aspire to help billions of people live longer, healthier, happier lives.”

 

We have a new and exciting opportunity to hire an ANZ Cross Sector Safety Lead – PV, for our Pharmacovigilance here at North Ryde, NSW, Australia office.

 

Be Vital in this role

 

Fulfil the responsibility for the coordination and execution of all Pharmacovigilance (PV) activities across the Pharmaceutical and Consumer sector to ensure that all of Johnson & Johnson’s statutory and ethical responsibilities are met. Act as the Local Operating Company (LOC)’s and assigned territories’ (Australia and New Zealand) main contact point for PV matters with the local Health Authority, Global Medical Organisation (GMO), Global Medical Safety (GMS) and Office of Consumer Medical Safety (OCMS). Provide strategic leadership and support LOC to meet all global and local PV responsibilities. Additionally, represents the company as the qualified person responsible for pharmacovigilance for Pharma and Consumer.

 

Some of the core Job Responsibilities are below:

The ANZ Cross Sector Safety Lead – PV will:

  • Be responsible for pharmacovigilance undertakings in Australia and New Zealand.
  • Be the Australian pharmacovigilance contact person responsible for reporting to the TGA and coordinating pharmacovigilance-related communications and all safety matters including all routine and ad hoc TGA PV inspections.
  • Oversee Pharma and Consumer product safety strategy and pharmacovigilance (PV) operations in Australia and New Zealand while maintaining highest level of compliance with local regulations and JNJ global policies.
  • Have key accountabilities for PV to the ANZ board of directors for both routine Key Performance Indicators (KPI) as well as safety issues.
  • Oversee development and implementation of local Risk Management Plans and proactively address any emerging safety concerns. Ensure fulfillment of safety obligations adopted as part of marketing authorizations and other commitments relating to the safe use of the products, including risk minimization measures and post-authorization safety studies requested by a health authority (HA).
  • Participate in product safety issue management with local and regional leaders and serve as a member of the ASPAC IPV Leadership Team.

Oversight of the PV System

  • Oversight of the full cross sector product portfolio, and link with local management and key stakeholders
  • Monitor and forecast PV workload to identify, mitigate and escalate potential PV resource and non-compliance issues.
  • Identify periods of high PV workload and manage PV resource appropriately to address them.
  • Support and lead process improvements to optimize the PV system and make best use of PV resource.
  • Provide high quality and consistent input to development of local safety initiatives and programs.
  • Plan and deploy skilled resources against project priorities, if applicable
  • Maintain an environment of continuous improvement within the PV team and contribute to continuous improvement initiatives across the region and globally with GMO, GMS and OCMS.

Collaborate & Support

  • Collaborate with Regulatory Affairs to forward any safety-related inquiry or relevant communication from the local RA to the appropriate global and regional groups as appropriate. Collaborate with appropriate departments to identify the resources and expertise needed to address the question. This may include local, regional and/or global expertise.

Collaboration with Medical Affairs for the review and approval of safety aspects of local study protocols to ensure appropriate safety reporting to GMS or appropriate case management center and Health Authority, as required.

 



Qualifications

Be part of something bigger than yourself in the Johnson & Johnson family of Companies

 

Qualifications, Experience, Skills and Knowledge:

  • The ideal candidate will be qualified with a medical, scientific or pharmacy degree with post graduate qualifications (Masters) or will have a life-sciences degree with a Ph.D.
  • 9-12 years of experience in PV essential; experience working in the pharmaceutical industry is strongly preferred
  • Adequate understanding of the Australian, New Zealand and global pharmacovigilance processes in order to allow them to have effective oversight of the entire pharmacovigilance system.
  • Strong people management and leadership compatibilities
  • Trained and experienced in pharmacovigilance and relevant legislation in Australia and New Zealand
  • Knowledge of PV regulations
  • Effective decision maker with the ability to assess impact of actions taken locally on the global PV system
  • Strong influencing skills with the ability to explain and defend a position which is in the best interests of patient safety

… apply online using the link below. You will receive an automated email confirming receipt of your application.. Every application is reviewed by the Talent Acquisition team and candidates will receive notification of the outcome of their application in a timely manner.

 

The closing date for applications is 23rd October 2018

 

Agencies please note: this recruitment assignment is being managed directly by Johnson & Johnson’s Talent Acquisition team. We will reach out to our preferred agency partners in the rare instance we require additional talent options. Your respect for this process is appreciated.

 

 



Primary Location
Australia-New South Wales-Sydney
Organization
Janssen-Cilag Pty Ltd (7490)
Job Function
Medical Affairs
Requisition ID
1805688297W