Johnson & Johnson Careers
PSMF Associate, QPPV Office
Requisition ID: 1905720847W
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.
We are looking for a Pharmacovigilance System Master File Associate to be responsible for the day to day maintenance of the Janssen PSMF and reporting to the PSMF and Operations Manager.
Although the PSMF is mandated by EU legislation, due to similar existing and emerging from regulatory authorities outside the European Economic Area (EEA). We will also require you to maintain of a ‘core’ PSMF and to support requests for the PSMF from impacted countries.
- You will be developing and maintain an understanding and organization of the components of the Pharma PV System and their interactions
- Coordinating the receipt of contributions from key contributors of PSMF Main Body and Annexes
- You will take primary responsibility for the timely collation of the EU PSMF and ‘core’ PSMF.
- Organising and storing ‘submission-ready’ (i.e. QC’d and revised, if required) contributions ready for collation.
- You will liaise with QPPV Office Medical colleagues to facilitate PSMF final proofread and QC checks for each PSMF update
- Your experience in maintaining a system/process will be necessary to track the PSMF schedule, the allocation and training of PSMF key contributors.
- Performing QC checks on contributions to ensure correct formatting and completeness of information
- Collating contributions into final document on request of QPPV (or designee), MAH or other regulatory authorities
- Prepare full PSMF versions and Annexes on a monthly basis ready for submission to regulatory authorities as required.
- Archive submitted versions in designated repository
- Performing any ad hoc activities that arise in relation to the complexity of PSMF management, and in the maintenance of tracking systems to assist with QPPV oversight
- Working collaboratively with key PSMF contributors to ensure that they are appropriately trained and aligning with the applicable policy.
Do you have the following Education & experience we require?
- Bachelor’s Degree.
- Work experience in pharmaceutical industry or regulatory authority is preferred. Experience in pharmacovigilance or regulatory affairs would be highly valued.
- Awareness and understanding of project management, with willingness to operate in a diverse, international matrix environment.
- Awareness of European pharmacovigilance legislation and the principles of global pharmacovigilance requirements.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United Kingdom-England-High Wycombe-
Janssen Cilag Ltd. (7360)