General Information

Job Advert Title
Sr Dir Aggregate Safety Assessment
Location
Netherlands, United Kingdom
Function/Business Area
Medical & Clinical
Department
Aggregate Safety Assessment I
Employment Class
Permanent

Description

Senior Director Aggregate Safety Assessment

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:

The Senior Director Aggregate Safety Assessment is responsible for development and maintenance of excellence in Aggregate Safety Assessment. Reports to the Executive Director, Medical Safety Analyses and contributes to the development and implementation successful execution of the GPV mission, objectives and 3--5-year strategic plan.

Key Activities are noted below:

  • Lead and oversee the periodic aggregate safety reporting activities in Global Pharmacovigilance (GPV) to enhance quality of Astellas pharmacovigilance activities and to ensure excellence in periodic aggregate safety reports mandated by worldwide regulatory authorities
  • Establish the best practice of periodic aggregate safety reporting activities as well as ad-hoc reporting to ensure the safety of Astellas' products
  • Ensure that GPV staff is fully and appropriately informed of, and trained on, global regulatory requirements and guidelines for periodic reporting
  • Establish and maintain closely alliances with relevant functions --both internal (GPV) and external (RA, GMA, Clinical Development) partners -- to ensure high-quality periodic reporting activities
  • Strictly comply with all relevant authorities / regulations
  • Leads, executes and oversees the worldwide ASA activities: both in-house and outsourced ASA activities.

Experience and Knowledge:

  • Strategy Development and Execution
  • Contribute to development and implementation of 1-3-year Medical Safety Science and Aggregate Safety Assessment specific objectives and plans as part of the overall GPV strategy and plans. Participates with the Executive Director, Medical Safety Analyses and as a member of the GPV Extended Management Team in the successful execution of GPV vision, mission, objectives and plans.
  • Develops and leads the successful implementation of annual Aggregate Safety Assessment strategic goals and objectives.

Technical Content:

The ASA Lead will be accountable for:

  • Global ASA Strategies
  • Develop and execute the budget for global ASA management
  • Develop and implement ASA strategy across the entire Astellas organization
  • Working closely with the Signal Management and Risk Management Leads, provide critical support to all the TA Heads
  • Managing outsourced vendors for periodic/ medical writing
  • Report scheduling and tracking of Aggregate Periodic Reports
  • Closely liaise with Regulatory Affairs
  • Operations of ASA
  • Establish high quality standards to periodic (e.g. PBRERs, DSURs) and ad hoc (e.g. benefit-risk assessment documents in response to Regulatory Authority requests) safety reports and other reports authored by other departments (e.g. study protocols, clinical study reports, Investigator's Brochure, product label), in terms of leading the authors of the safety/medico[1]scientific sections and contributing to overall analyses and conclusions.
  • Provide expert guidance and close support to all TA heads and leads, and establish and monitor operations of PBRER, PADER/PAER, DSUR, ACO and IPSR and others as appropriate
  • Accountable for compliance with regulatory standards and timely delivery of all global and regional periodic documents of high quality in collaboration with RA and Global PV
  • Build and maintain close cross-departmental and cross-divisional relationships with all function heads in global pharmacovigilance, including EU-QPPV and JP-QPPV, RA, GMA and Clinical Development
  • Supports regulatory strategy and preparation of safety-related data for submission to Health Authorities
  • Ensure quality, accuracy, timeliness and efficiency of ASA activities and results
  • Collaborating with other members of Medical Safety Science
  • Support the functioning of the TA Leads
  • Establish relationship with, and support of, other functions within Medical Safety Science
  • Build and maintain close relationships with all functions within GPV, as well as responsible for cross-departmental interactions with relevant functions
  • Together with the TA Head and Leads, share accountability for responses to both global and regional authorities.
  • Quality Management
  • Supports PV inspection/audit issues as an ASA expert contributing to non-PV inspections/audits (e.g. GCP) as necessary and supporting the QPPV office in corrective and preventive action plans related to medical safety.
  • Maintains up-to-date knowledge on regulations related to ASA Management and advises the Executive Director, Medical Safety Analyses on the impact of any new or revised ASA regulations
  • Contributes towards the development of the pharmacovigilance ASA training curriculum and is responsible for the correct (medico-scientific) content of training materials.
  • Represents Global PV in large (cross-) functional ASA training sessions promoting pharmacovigilance awareness and providing ASA specialist education across internal and external audiences.
  • Advises the Executive Director, Medical Safety Analyses in optimizing cross-functional process improvement initiatives within the field of ASA, to produce or strengthen consistent and standardized ASA processes across the organization.
  • People & Organization Management
  • Responsible for the effective implementation of optimal organizational structure(s) which maximizes on the use of resources globally and reflects business needs and conditions.
  • Develops an environment to enable each member of Aggregate Safety Assessment to optimally operate in the matrix environment of GPV and Astellas.
  • Manages the Aggregate Safety Assessment function and its people, through successful recruitment, performance management, development planning and retention of a high performing team.
  • Effectively delegates responsibilities to achieve ASA goals and effectively develops and aligns individuals to the best of their abilities, while ensuring optimal oversight and supervision to ensure goals are achieved and appropriate growth in technical, leadership and team membership skills.

Qualifications:

  • A postgraduate Science or Medical degree ( PhD, MS, Pharm.D, MD). Additional degree in public health concentration is desirable (e.g. MPH, Epidemiology, etc.).
  • Extensive experience in the health science-related industry with direct exposure to clinical, regulatory or pharmacovigilance functions including;
  • Significant pharmacovigilance experience (advanced pharmacovigilance functions from development and post-authorization)
  • Management or team experience, managing academic level professionals (e.g. physicians, scientists).
  • Direct management experience.
  • Significant and demonstrable working knowledge of global pharmacovigilance regulations and guidelines, including US, ICH and EU regulations.

Additional information:

  • Currently this position has the flexibility to work from home and in the office.
  • This is a permanent full-time position based in the UK or in the Netherlands, or in US or in Japan.

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.