Job Detail

Stellenbeschreibung

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. We have more than 260 operating companies in more than 60 countries employing approximately 134,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

As part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Actelion is working to create a world without disease. Actelion is a leader in the field of pulmonary arterial hypertension (PAH). The portfolio of PAH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications.

Main Responsibilities

Responsible for the case processing of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations and corporate policies.

• Triage of incoming cases to prioritize for daily workflow management


• Completion of remaining case data entry (including narrative or autonarrative), manual coding, label and approval


• Preparation of SUA summary: Analysis of Similar Events


• Perform quality review of ICSR which includes review of source documents and ensuring that the case is accurate and that corrections to the case, if applicable, are incorporated


• Liaison with Case Receipt and/or Safety Surveillance Physicians (SSP) staff as appropriate to clarify appropriate information required for case processing


• Participation in local or global project teams, including on-time delivery of assigned responsibilities

Qualifikation

• Registered Nurse or Pharmacist (Certification/licensure is required e.g. RN, RPh, PharmD)


• Health/Biomedical Degree (BS, PhD or other related scientific degree/qualification)


• Pharmaceutical industry experience is preferred


• Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are preferred


• Understanding of medical terminology and ability to summarize medical information


• Ability to follow guidelines and procedural documents

This role based in Allschwil, Switzerland will initially be limited to approx. 6 months. If you are interested in working for a global leading health care company in a challenging role, then send us your application in English today. Or give us a call if you have any questions!