- 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)
- 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
- 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)
- 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.
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Pharmacovigilance Affiliate Drug Safety Associate - CH- Wallisellen, Schweiz - Astellas Pharma AG
Beschreibung
General Information
Job Advert Title Pharmacovigilance Affiliate Drug Safety Associate - Alpine Location Switzerland Function/Business Area Sales & Account Development Department PV Affiliate Management Established Markets - Switzerland Employment Class PermanentDescription
Pharmacovigilance Affiliate Drug Safety Associate - AlpineAbout Astellas:
At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.
Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It's a culture of doing good for others and contributing to a sustainable society.
Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.
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.
Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.
We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.
Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.
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:
