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Job Advert Title
Senior Director Affiliate Management
Locatie
Nederland
Function/Business Area
General Management
Afdeling
PV Affiliate Management Established Markets
Werkcategorie
Arbeidsovereenkomst voor onbepaalde tijd

Functiebeschrijving

Senior Director Affiliate Management

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:

Responsible for development and maintenance of excellence in Regional Affiliate Management. Reports to the Head of Affiliate Management is a member of the Affiliate Management team and contributes to the development and successful implementation execution of the PV mission, objectives and significant years of experience in the strategic plan.
This position interacts across a cross-functional matrix of internal and external pharmacovigilance stakeholders, as well as with Astellas' global Pharmacovigilance counterparts. The Affiliate Lead is responsible for developing strategies and implementing Pharmacovigilance activities for affiliate partners and Drug Safety Officers (DSOs in the assigned region).
This position oversees and directs the safety operations of affiliates by establishing effective communications, developing agree-upon processes and ensuring execution against those processes in line with local regulations and Astellas standards.
This position interacts across a cross-functional matrix of internal and external pharmacovigilance stakeholders, as well as with Astellas global Pharmacovigilance counterparts.

Key Activities are noted below:

  • Strategy Development and Execution Contribute to the development and implementation of significant years of experience in Regional Affiliate Management specific objectives and plans as part of the overall Pharmacovigilance strategy and plans. Participates with the Affiliate Management and as a member of the Pharmacovigilance Extended Management Team in the successful execution of Pharmacovigilance vision, mission, objectives and plans. Develops and leads the successful implementation of annual Regional Affiliate Management strategic goals and objectives. Provide safety leadership and strategic direction to the local functions in assigned region (e.g.affiliates incl. the DSO, Pharmacovigilance representatives from Astellas' Agents or the Safety Management Implementation Personnel). Manage and lead the affiliate management team within Pharmacovigilance.
  • Organization & Planning Monitor changes in workload and recommend changes in headcount / resources as required – resolve or escalate if insufficient resources are made available by the local office
  • Identify and / or follow up on local specifics and constraints in terms of Pharmacovigilance organizational set-up and ensure they are consistent with legislation and Astellas standards
  • Analyse, assess and follow up affiliates' organization relevant to Pharmacovigilance, and highlight any issues and/or shortcomings to the head of Affiliate Management and local country management in the case of Europe.
  • Define with head of Affiliate Management and Qualified Person responsible for Pharmacovigilance in Europe and Japan the global and/or local Pharmacovigilance related objectives, according to local requirements/situations and communicate these with the local offices.
  • Determine Pharmacovigilance specific resource/headcount needs (including back-up and local Qualified Person as required by local regulations) and manage with local or regional management to establish a robust network of DSOs and Agents in the assigned region.
  • Define the role and responsibilities of Affiliate DSO in assigned region, and act as Line / functional manager of DSOs.
  • Relationship Management
  • Manage the relationships between the Pharmacovigilance and local offices (including local affiliates and DSOs).
  • Establish close interactions with relevant departments (e.g. Regulatory Affairs, Medical Affairs, Clinical Operations, Market Research, Customer Care) at local/ regional level to ensure cross functional collaboration and compliance.
  • Be the first point of contact for potential safety issues identified by the local offices (including affiliates and/or DSOs).
  • Ensure local stakeholder (including affiliates and/or DSO) input in relevant projects/initiatives and ensure proper implementation
  • Maintain regular communications to create awareness, understanding, training and support for the Pharmacovigilance-related tasks within the local office structure and within the Pharmacovigilance structure.
  • Set up regular meetings or teleconferences as appropriate for internal communication with and between the local offices (including affiliates/DSOs) in the assigned region. Regularly visit the affiliates - prioritize visits with a risk-based approach to evaluate the Affiliate's performance, compliance and Inspection Readiness, in a systematic fashion.
  • Actively collect and evaluate input for continuous improvement of Pharmacovigilance practices from the local office ((including local affiliates and DSOs). Propose and implement identified improvements together with Affiliate Operations.
  • Affiliate staff performance and training.
  • Ensure training requirements for local office staff, DSOs and affiliates are established and training is completed in a timely manner and documented appropriately.
  • Ensure recruitment, and developing affiliate DSOs and Pharmacovigilance staff of the assigned region(s)
  • Define Key Performance Indicators (KPIs) including Data Quality KPIs for the affiliates and/or DSOs and measure and report on to Pharmacovigilance management. Audit readiness & response.
  • Provide tools for Inspection Readiness self-assessment and supervise the regular evaluations of all Affiliates and DSOs and initiate and monitor Action Plans to reach full compliance as applicable.
  • Coordinate and participate as required in the preparation, conduct, and follow-up of audits and inspections occurring at the affiliates and/or DSOs.
  • Ensure appropriate corrective and preventive action (CAPA) plans are prepared and implemented in follow up to audits and inspections, working closely with Quality Management System Lead.
  • Provide input to CQA for audit planning purposes. Quality & Compliance Management
  • Manage individual DSOs and/or local office PV activities to maintain the Astellas PV system and Qualified Person for the Pharmacovigilance oversight.
  • Responsible for initiating, implementing, reviewing & oversight of all Pharmacovigilance-related activities according to international regulations, Astellas procedures, the DSO role description and Affiliate Agreements.
  • Coordinate and assess the nature and urgency of potential safety issues and other issues and take appropriate action and/or report in timely manner to relevant function(s) or department(s).
  • Ensure implementation of regulatory intelligence to maintain knowledge of local requirements and regulations and changes thereof and ensure correct implementation of any identified changes. Inform EU Qualified Person for the Pharmacovigilance and Strategy & planning group of relevant and/or major changes.
  • Ensure appropriate quality investigations and corrective actions are taken in case of noncompliance or poor performance for data quality KPIs.
  • Ensure that the required steps for corrective actions are implemented by the affiliates and/or DSOs, monitor progress, and support the affiliates and/or DSOs as needed and follow up to completion.
  • Collaborate with the Affiliate Operations group to maintain oversight of local SOPs and/or working procedures held by the affiliates and/or DSOs and ensure alignment with Pharmacovigilance procedures.
  • In collaboration with DSOs, monitor compliance / business status related to safety operations and take corrective actions as needed, this position requires deep and broad range of knowledge not only for each country’s Pharmacovigilance regulation and also for differences in Pharmacovigilance regulations in each country all of which are non-ICH nations.
  • 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. Manages the Regional Affiliate Management function and its people, through successful recruitment, performance management, development planning and retention of a high performing team. Effectively delegates responsibilities to achieve Regional Affiliate Management 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. Responsible for the development and maintenance of effective collaborations with internal Pharmacovigilance key stakeholders and functions, as well as of relevant external stakeholders:
  • With the Lead of Training for close alignment of training activities related to local office Pharmacovigilance activities.
  • With the Lead of Quality Management System for close alignment of Quality Management System activities related to local office Pharmacovigilance activities.
  • With the Lead of PVA for close alignment of fulfilment of Memorandum of understanding between GM of affiliates.
  • With the Lead of Risk Management for close alignment of implementation of RMP in the assigned region.

Experience and Knowledge:

  • Extensive experience in the pharmaceutical industry with at least significant experience in Pharmacovigilance.
  • Significant experience in managing staff preferred, experience in sales and marketing department preferred.
  • Knowledge of Drug Safety and Regional and Global safety regulations and requirements.
  • Leadership and management skills, (ability to analyse complex situations and take decisions with a pro-active and service-oriented attitude.
  • Ability to interpret and translate guidelines and/or legislation into operating procedure.
  • Fluency in English (verbal and written).
  • Competency in additional languages is preferred, especially for regional positions.
  • Knowledge of Microsoft office.
  • Organization and Planning: ability to establish priorities, co-ordinate tasks, time management.
  • Able and willing to travel internationally (between 25- 50%).
  • The preferred location for this position is in the PV Regional Office within the assigned region.

Qualifications:

  • Bachelor degree in (Bio)medical or Life Sciences.

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.

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.