Affiliate Pharmacovigilance Manager

Affiliate Pharmacovigilance Manager

About Astellas:

At Astellas we are a progressive health partner, delivering value and outcomes where needed. 

We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions. 

We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. 

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 work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes. 

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care. 

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.