PSMF Coordinator

Job description

Job Description

Requisition ID: 1905718389W

" Caring for the world… one person at a time ” … inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo

Actelion is a leader in the field of pulmonary hypertension (PH). Our portfolio of PH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications.

As part of the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it.

Actelion Pharmaceuticals, a Janssen Pharmaceutical Company of Johnson & Johnson, is recruiting for an:

T he Pharmacovigilance System Master File (PSMF) Coordinator

PSMF Coordinator responsibilities include:

·  Coordination and management of the quarterly or ad hoc Call for Information (CFI)
·  Conduct follow-up activities on identified irregularities in data provided and send reminders for pending input after deadline
·  Coordination of meetings relevant to the PSMF, as needed
·  Organization and filing of relevant documents;
·  Collaboration with Global Regulatory Affairs for the timely publication of the PSMF in ITrack
·  Contribution to the update and publication of relevant Standard Operating Procedures;
·  Planning and participation in EU QPPV Office meetings, as needed;
·  Daily monitoring and filing of EU QPPV Office mailbox incoming emails;
·  Support compliance activities through inspection readiness activities, participation in audits and inspections related to the EU QPPV Office
·  Processing expense reports (e.g. travel);

Desired profile

Qualifications

· 
Bachelor's degree or equivalent education.

· 
Experience in the pharmaceutical or biotechnical industry, training in a health related field, or knowledge of medical terminology and familiarity with disease processes is a plus.

·  Computer proficiency (Word, Powerpoint, and Excel); knowledge of safety databases or the ability to learn new systems;
·  Ability to communicate effectively in English (spoken and in writing); French and/or German are helpful;
·  Attention to detail;
·  Ability to prioritize tasks;
·  Ability to work independently on routine tasks;
·  Good organizational and problem solving skills;
·  Ability to work under pressure and to meet tight timelines

If you are interested in making an impact by working in a culture of innovation, trust and teamwork, we welcome your online application by clicking here.

Primary Location
Switzerland-Allschwil--
Organization
Actelion Pharmaceuticals Ltd (Swiss Confederation) (8542)
Job Function
Administration
Requisition ID
1905718389W