We are currently hiring a Local Qualified Person for Pharmacovigilance (L-QPPV) in Austria. The role will be reporting directly into the Pharmacovigilance Affiliate Management Established Markets

At Astellas, we are making treatments that matter to people. We are tackling the toughest health challenges putting the patient at the heart of every move we make.

We have developed ground-breaking, innovative medicines in immunology, oncology, and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible, and improving the quality of life for those living with conditions where needs are often overlooked.

We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients’ lives.

From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.

Responsibilities:

- Lead and manage the affiliate Pharmacovigilance (PV) department and act as the primary contact for any safety issues at the responsible affiliate

- Act as the local Drug Safety Officer (DSO) and manage its related duties

- Ensure compliance and its timelines towards local PV regulations

- Being accountable for representing Astellas towards the local Health Authorities

- Provides PV leadership and strategic direction to the local PV department in affiliate

- Ensure implementation, annual delivery, and documentation of PV Product Safety

- Overseeing the PV training plan of the affiliate and proactively inform on any changes

Requirements:

- Minimum BA/BS degree (Pharmacy, Medical Degree or Biomedical/Life Sciences preferred), relevant external pharmaceutical (professional) training with an advanced professional degree.

- Minimum of 2+ years relevant experience in pharmacovigilance

- Understanding of local and/or regional Pharmacovigilance requirements and directives. 

- Robust knowledge of PV procedures and comprehensive experience operating within PV pharma roles

- Experience in preparation for audit, conducting audit and post-audit reporting, and monitoring of CAPA actions

- Ability to demonstrate effective decision power and leadership to ensure local PV system and related activities at the affiliate level, including compliance, are always maintained at the highest standards

- Proficiency in German language and business English language (written, verbal, presentation, facilitation)

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.