Johnson & Johnson Careers
Senior Pharmacovigilance Associate
Drug & Product Safety Operations
Requisition ID: 1905726086W
Sydney based – North Ryde
Exposure to various therapeutic areas
Pharma and Consumer
Be Vital in this role…
Reporting to the ANZ Cross Sector Safety Lead for ANZ, this exciting position will be responsible for product safety strategy and pharmacovigilance (PV) operations in ANZ associated with the use of Johnson & Johnson products in accordance with regulatory and corporate requirements.
Key responsibilities & competencies include:
Oversight of case management in accordance with established Local Health Authority requirements, Local Operating Company and Global Medical Safety SOPs.
Provide expert guidance to case processing team, resolve complex cases and contribute to operational excellence.
Provide high level input into the development and review of local SOPs to ensure compliance with HA requirements and global company requirements. .
Review compliance metrics and perform analysis of non-conformance reports; drive the implementation of any corrective actions.
Represent Pharma and Consumer safety strategic and operational interests in Australia and New Zealand and serve as a key interface between global functions, regional leadership and the local operating companies
Advise the business on the PV impact of post-marketing initiatives and associated PV vendor management.
Provide high level input into safety sections of local clinical studies, health economic and marketing proposals for compliance with company and regulatory safety reporting requirements.
Provide technical and strategic input and participate in projects led by the regional and global teams.
Participate in audits and health authority inspections and execute any CAPAs as required.
Key working relationships include:
External – TGA, MedSafe, Consumers, health care professionals, Medicines Australia, Industry groups, vendors and others
Internal – personnel from various departments/functions (i.e. Sales, Marketing, Medical Affairs, Health Care Compliance, Clinical, Regulatory, Legal etc.)
Be valued for who you are…
Key to success in this position will be your proven ability to demonstrate the following in a complex environment:
- Build and maintain strong relationships
- Excellent communication skills
- Proven organizational and project management skills
A collaborative, results-orientated style and approach
High integrity and work ethics, in line with our company's core values
Qualifications and experience required:
- A degree in pharmacy or life science
- A minimum of 6 years’ experience in pharmacovigilance
- Competence in MS Office Applications (MS Word, Outlook, Access, Excel)
Be part of something bigger than yourself…
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world.
Please submit a résumé & cover letter in application.
If you have experience in pharmacovigilance, 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.
The closing date for applications is Friday 29th March 2019.
Australia-New South Wales-Sydney-
Janssen-Cilag Pty Ltd (7490)
Drug & Product Safety Operations