Johnson & Johnson Careers

Pharmacovigilance System Master File Coordinator

Warsaw, Poland

Job Description

Requisition ID: 1805692122W

The Johnson & Johnson Family of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and non-prescription pharmaceutical products.
Our mission is to care for people around the world by developing innovative products and solutions that are grounded in deep human insights, backed by science that is intuitive, and provide irresistible experiences. To support our Worldwide Research & Development operation, we are building a complex R&D support center in Warsaw, Poland, to be fully integrated in the global R&D footprint and strategy, helping consumers live healthy and vibrant lives.
Pharmacovigilance System Master File Coordinator
Location: Warsaw, Poland
Full time permanent contract
Role Overview:
The Pharmacovigilance System Master File (PSMF) Coordinator coordinates the preparation of the PSMF and PSMF Summary in accordance with the assigned schedule.  The PSMF Coordinator ensures the content of the PSMF is complete by liaising with key contributors to ensure content is provided in a timely manner, collating the data and circulating for review as appropriate.
You will have the following areas of responsibility:
  • Maintaining calendar documenting schedule of data requirements for the PSMF
  • Coordination of the call for information/email reminders to contributors ahead of due dates for submission
  • Liaising with other global functions to collate required information within timelines
  • Circulation of sections of PSMF and annexes as appropriate for review
  • Maintain tracker of controlled documents for inclusion in Annex E to the PSMF
  • Upload completed PSMF and PSMF Summary into Connect and ensure contributing documentation is archived in accordance with PSMF SOP
  • Support QPPV oversight of submission of the PSMF
    • Maintain tracker of requests for the PSMF Summary
On an ad hoc basis, the PSMF Coordinator may also perform additional document management activities including uploading of documents into the Connect system and as needed and provide general support to the QPPV Office.

Qualifications and experience of the successful candidate:
  • Bio Science Degree, pharmacy or nursing degree
  • Experience in drug safety preferred (2 years)
  • Experience with Microsoft Word, Excel and PowerPoint and Visio
  • Strong tracking, coordination and project planning skills
  • Excellent customer service, interpersonal, communication and team collaboration skills
  • Good communication skills, both written and verbal
  • Able to identify and implement process and/or application improvements
  • Able to work on multiple simultaneous tasks with limited supervision
We Offer:
  • Unique opportunity to become part of a global consumer healthcare market leader
  • Versatile and fulfilling role in a dynamic and international corporation
  • Work in a supportive and highly professional team
  • Further opportunities for professional development and career growth
  • Motivating financial remuneration & numerous employee benefits
If you are interested in this role and you fulfill the requirements set above, do not hesitate to send us your CV and cover letter in English.

Primary Location
Johnson & Johnson (Poland) Sp. z.o.o. (7815)
Job Function
Requisition ID