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 the Affiliate Pharmacovigilance Manager, you will play a pivotal role in safeguarding patient safety and ensuring compliance with regulatory requirements at the local affiliate level. You will serve as a key liaison between the affiliate and regional/global Pharmacovigilance leadership, contributing to the development and execution of strategies to enhance PV operations and meet organizational objectives. By overseeing the execution of Pharmacovigilance activities, you will uphold Astellas' commitment to integrity and the delivery of the highest standard of quality in compliance with all applicable regulations and ethical standards.
Your responsibilities will extend beyond operational management to encompass strategic planning, risk mitigation, and stakeholder engagement. You will collaborate closely with cross-functional teams, including Medical Affairs, Regulatory Affairs, Quality Assurance, and Legal, to ensure alignment and coordination in achieving Pharmacovigilance goals.
Hybrid working:
At Astellas we recognize that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.
In this role, you will:
- Contribute to the implementation of Global, Regional Affiliate Management, and Local specific objectives and plans as part of the overall PV strategy.
- Execute processes and activities to enhance compliance, efficiency, and overall effectiveness of the affiliate PV department.
- Ensure safety information received from all sources is collected, translated, and forwarded to designated Regional Global PV Headquarters in compliance with required timelines and quality guidelines.
- Conduct PV activities in alignment with regulatory requirements and internal Astellas procedures to ensure full compliance.
- Provide input for the Pharmacovigilance System Master File (PSMF) regarding affiliate communication to GPV regional Headquarters.
Essential Knowledge & Experience:
- Proven years of experience within PV, including direct contact and engagement with national competent authorities.
- Good understanding of establishing and maintaining Quality Management Systems (GxP).
- Proficiency in French and a business level of English language.
- Ability to work independently and in a matrix structure.
Education:
- Pharmacist’s degree or equivalent.
Preferred Knowledge & Experience:
- Project management experience.
- Scope, interdependencies, budgeting, critical path analysis, and reporting experience.
Additional information:
- This is a permanent, full-time position.
- This position follows our hybrid model. Role requires a blend of home and a minimum of 2 days per week in our Levallois-Peret office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.
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.