Pharmacovigilance 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:
This is an exciting opportunity where you will be responsible for the development and maintenance of excellence in Pharmacovigilance (PV) activities within Egypt, Algeria and Morocco. In addition, you will also act as the deputy of the local qualified person for PV (L-QPPV), in South Africa. The role will be based in Cairo, Egypt, reporting directly to the PV Area Head, MEA and Turkey.

As a Pharmacovigilance Lead, you will have the opportunity to be part of the Global PV community at Astellas offering a global exposure and the chance to be involved in global projects.

Key Activities:

- Ensure a company culture in which pharmacovigilance and compliance form a fundamental part of business processes.
- Responsible for developing and implementing procedures to ensure compliance with both local and regional PV regulations and Astellas global and regional policies and procedures.
- Manage relationships within affiliate and with PV Affiliate Management Function colleagues on matters relating to operational management and compliance that are impacting PV.
- Contributes to development and implementation of 1-3 year Global, Regional Affiliate Management and Local specific objectives and plans as part of the overall PV strategy and plans.
- Manages local business partners and coordinates the required contribution from the local business partners to the PV system and requirements.
- Contribute to the maintenance of a Local Quality Management System (QMS).
- Ensures that all Individual Case Safety Reports (ICSRs) are captured, tracked and managed in LSIT (LifeSphere Intake and Triage) in accordance with applicable standards and procedures.
- Coordinates and executes the conduct of PV self-assessments, PV audits/inspections at the affiliate and assist in developing CAPAs (with qualitative/quantative measures and timelines) in response to findings/observations

Essential Knowledge & Experience:

- Substantial experience in Pharmacovigilance, Compliance and/or Quality in the Pharmaceutical or Biotech Industry and to include direct contact and engagement with national competent authorities.
- Experience with/ and understanding of PV Processes, Standards &Training.
- Experience with establishing and maintaining (GxP) Quality Management Systems
- Experience with preparation for audit, conducting audit and post-audit reporting and monitoring of CAPA actions
- Previous experience in the country of responsibility is preferred;
- Proficiency in written/verbal English and Arabic. French would be an added advantage.

Preferred Knowledge & Experience:

- Able to take ownership with pro-active attitude and ability to work independently;
- Excellent communication skills and ability to develop and maintain good working relations with internal and external stakeholders
- Project management experience (scope, interdependencies, budgeting, critical path analysis, reporting etc).

Educations/Qualifications:

- Minimum BA/BS (Pharmacy, Medicine) or equivalent

Additional information:

- Full time, permanent position
- Role is Based in Cairo, Egypt

What We Offer:

- Being part of a global organization contributing towards improved patient lives
- Opportunity and support to continuous development

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