Pharmacovigilance Affiliate Drug Safety Associate - Alpine

About Astellas:

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.

Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.

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.

About this Job:

As Pharmacovigilance Affiliate Drug Safety Associate, you will be an essential member of the team at our Alpine affiliate (Austria, Liechtenstein, and Switzerland), with a primary focus of around 80% on Switzerland. In addition to ensuring day-to-day operations, you will act as Deputy Local QPPV (L-QPPV) for Switzerland and Deputy Drug Safety Officer (DSO) for Austria.

Key Responsibilities:

Business continuity, quality and compliance for local PV tasks and responsibilities
Local case processing, local literature review
Interactions with Swissmedic regarding drug safety signals
Implementation of additional Risk Minimization Measures
Quality Management System (e.g., audits / inspections, third party life-cycle management)

Essential Knowledge & Experience:

Previous experience in PV or a PV role combined with RA and/or QA
Experience with local case processing activities in a safety database (ICH E2B format) preferred
Ability to work independently, result-oriented, adept at meeting timelines while effectively managing fluctuating workloads
Proficient with Microsoft Office applications

Education/Qualifications:

BA/BS (Pharmacy, Medical or Biomedical/Life Sciences preferred), or equivalent
Familiar with current local and regional PV regulations/guidelines
Quality mindset, adequate understanding of GxP Quality Management System requirements
Good communication and collaboration skills
Proficiency in German (native speaker) and English (min. level C1), preferably in combination with French and/or Italian (min. level B2)

Additional information:

This is a permanent, full-time position.
Location: Switzerland (Zurich/Wallisellen)
This position follows our hybrid working model. Role requires a blend of home and a minimum of 2 days per week in our office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.
Flexible availability (e.g., during summer holidays) is preferred given the role of Deputy.

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.