QPPV & Stufenplanbeauftragter (m/w) Job ID: 10358

Drug Safety

Our customer is an ambitious, independent service provider in pharmaceutical development, international regulatory affairs and drug licensing located in Southern Germany between Basel and Freiburg. The clients are pharmaceutical and biopharmaceutical companies of all sizes from Europe and abroad. Our customer is highly committed to the success of his clients, and works to highest quality standards. To further strengthen his Medical Team, we are now searching exclusively for a Pharmacovigilance Expert as QPPV and Stufenplanbeauftragter (m/w)

Ihre Aufgaben
  • Cooperate with servicre and consulting clients of our client to provide pharmacovigilance service, either on a local German or on an EU level. This also includes routine pharmacovigilance tasks.
  • Maintenance  and/or establishment of clients pharmacovigilance system concerning having an oversight over the functioning of the system in all relevant aspects, including its quality system
  • Acting as a single point of contact for pharmacovigilance for the competent authorities and the EMA in the function of the EU QPPV/Stufenplanbeauftragter
  • Risk assessment expertise
  • Providing input into the preparation of regulatory action in response to emerging safety

Ihr Anforderungsprofil
  •  Medical Doctor, Biologist, Pharmacist or other life scientist
  • Experience in Pharmacovigilance on a local German and EU level
  • Knowledge of EU Pharmacovigilance legislation and preferably experience with data submission to EudraVigilance
  • Willingness to liaise with clients for various levels of PV consultancy
  • High ethical standards as well as personal credibility
  • Able to work effectively and collaboratively across the PV Team
  • Has the expertise, determination and courage to resolve or escalate issues as appropriate
  • Good German language skills are necessary, English language skills fluid in speaking and writing
Auf Anfrage
Auf Anfrage
Moritz von der Brelie
Senior Manager Business Development Schweiz
Fon +41 41 510 04 90
Moritz von der Brelie
Senior Manager Business Development Schweiz
Fon +41 41 510 04 90
Mail moritz.vonderbrelie@theentourage.ch
Betreff Bewerbung für Job ID 10358 auf theentourage.de