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R&D

Senior Pharmacovigilance Associate

  • Titre Senior Pharmacovigilance Associate
  • Fonction R&D
  • Sous-fonction Drug & Product Safety Operations
  • Lieu Sydney, New South Wales, Australia
  • Date de mise en ligne
  • Référence 2206091714W
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Description

  • Great Place to Work® Certified - 2022 
  • Exposure to various pharmacovigilance activities and therapeutic areas
  • J&J benefits include: Onsite parking, Gym, Fitness Reimbursement, Volunteer Days, and much more!
  • Preferred Location: NSW + flexible work practices 

ABOUT THE COMPANY

At Janssen, everything we do is engineered with the patient in mind. It drives us to search for new ideas and innovative healthcare solutions. We embrace challenges and develop treatments that will change the lives of our patients.


We believe in connecting our own expertise and capabilities with those of others, seeking the most creative minds in every field. Together we can find transformational solutions.


At Janssen, we collaborate with the world for the health of everyone in it.

THE OPPORTUNITY


Be part of an exciting and rewarding role where you will lead and partner with Janssen's key stakeholders to shape and execute the pharmacovigilance activities for Australia and New Zealand.


You will be responsible to ensure that the Local Operating Company (LOC) safety activities are managed in compliance with local regulations and company policies/procedures at a local, regional, and global level and in accordance with any pharmacovigilance agreements with third-party business partners.

Reporting to the Country Safety Team Lead Australia & New Zealand of International Pharmacovigilance, your key focus will be to;

RESPONSIBILITIES

  • Collaborate with the local operating company (LOC), regional and global affiliates to enable the fulfilment of regulatory responsibilities (including pharmacovigilance agreement) 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. Track/oversight of the implementation of additional risk minimisation activities and ASA commitments
  • Assess PV impact of company-sponsored Related Research Activities (RRAs) and conduct training on PV requirements to internal stakeholders and external vendors ensuring systematic collection of safety data from company-sponsored RRAs and oversight to ensure PV compliance
  • 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

Qualifications

IT’S ALL ABOUT YOU

  • 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
  • Excellent verbal and written communication skills, presentation skills

COMPANY CULTURE 

You will be rewarded through a competitive remuneration package along with continuous training, support and award-winning leadership development programs. 

Being part of Johnson & Johnson can change everything, including YOU:

Janssen is driven by dedication to product innovation, customer focus, and organisational excellence. From research to real-life solutions, Janssen has a long track record in developing and marketing treatments that make a real difference.

Great Place to Work® Certified– 2022  

Great Place to Work® Certification recognises employers who create outstanding employee experience. The certification process is recognised worldwide as the global benchmark for identifying outstanding workplaces.  

Johnson & Johnson - Australia and New Zealand was certified as a Great Place to Work® in ANZ in its first year of participation. 

If you are interested, please 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. 

Closing date: 11:59pm Friday 17th February 2023. 

Johnson & Johnson is an equal opportunity employer who supports inclusive, flexible and accessible working arrangements for all. This includes persons with disabilities, culturally, religiously and linguistically diverse people, diverse age groups, diverse sexual orientation, and gender. 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. We draw pride and strength from you, your colleagues and the world we care for—all backgrounds, beliefs and the entire range of human experience—coming together to bring health to billions.

As a leading global healthcare provider, Johnson & Johnson has implemented a COVID-19 Vaccine Policy in Australia which requires all staff to be fully vaccinated for COVID-19 in order to commence work , unless they have a valid exemption.  

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.

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