Pharmacovigilance Affiliate Lead

About 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 Lead, you will be responsible for leading and managing the affiliate Pharmacovigilance (PV) department. You will be the primary contact for any safety issues at the responsible country and/or affiliate. Act as the local Drug Safety Officer (DSO) and manage its related duties. Act as the local qualified person for Pharmacovigilance (if applicable) with a personal accountability and representing Astellas towards the local Health Authorities. In addition, this role contributes to the development and successful implementation and execution of the Pharmacovigilance Affiliate Management Mission and Strategies, objectives, and solid experience in strategic plan.

You will be part of an inclusive team that works to develop innovative therapies for patients.

Essential Job Responsibilities:

- Leading and managing the affiliate Pharmacovigilance (PV) department
- Management of Product Safety Information
- Pharmacovigilance Quality and Compliance
- Maintenance of Pharmacovigilance System and Oversight Responsibilities
- Relationship management and Training

Essential Knowledge & Experience:

- Significant experience in pharmacovigilance or combined Pharmacovigilance/Regulatory Affairs/Quality Assurance, and/or clinical development, good experience in project management
- Member of professional Pharmacovigilance bodies and/or associations
- Understanding of local and/or regional Pharmacovigilance requirements and directives
- Expert knowledge of safety profiles of all marketed products in the country/affiliate
- Robust knowledge of Pharmacovigilance procedures. Knowledge acquired typically comprehensive experience operating within Pharmacovigilance pharma roles and/or regional PV role
- Fluent in English and German and good knowledge of French

Preferred Knowledge & Experience:

- Former working experience in Pharmacovigilance, e.g. preparation for audit, conducting audit and post-audit reporting and monitoring of Corrective And Preventive Actions
- Demonstrates effective decision power and leadership to ensure local Pharmacovigilance system and related activities at affiliate level, including compliance are always maintained at highest standards
- Former working experience with a multidisciplinary team
- Able to generate insights and leverage learnings at the individual, team and functional level

Educations/Qualifications:

- Minimum Bachelor’s degree or Master Degree (pharmacy, medical degree or biomedical/life sciences preferred) or equivalent

Additional information:

- This is a permanent full-time position
- Position based in Wallisellen, Switzerland

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.

**Job Type**: Permanent

Work Location: In person