Head, Safety Policy and Process Oversight, QPPV Office Janssen - Janssen Pharmaceuticals - Belgique
Johnson & Johnson Family of Companies
Région
Belgique
Caring for the world, one person at a time, inspires and unites Johnson & Johnson. J&J embraces research and science – bringing innovative ideas, products and services to advance health and well-being. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. J&J has more than 250 companies located in 60 countries around the world.
Who is Janssen?
We’re more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. From heart disease to HIV, Alzheimer’s disease to cancer, we are committed to issues that touch everyone’s lives.
Our Mission and Vision:
Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it. So, every day, in more than 150 countries, we bring cutting-edge science and the most creative minds in the industry together to think differently about diseases. We aim not only to innovate, but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health.
We are looking at a future where the world of healthcare will be challenged by informed and empowered patients. We work for change that will improve access to medicines: the best available treatment at an affordable price. That’s why we at Janssen strive to provide access to effective and affordable medicines and related healthcare services to the people who need them.
JOB RESPONSIBILITIES
Leadership and oversight of PV Policy activities within the Global Medical Organization and Janssen will be including :
Enabling proactive compliance with global PV-related legislations and ensuring EU QPPV oversight on PV legislation evolutions and implementation activities through:
- Coming, new and revised PV regulations:
- Existing PV regulations:
- Ensuring all requirements and results/outcomes are documented and retrievable for inspection readiness purposes
- Developing and implementing strategic plans for PV Policy activities in GMO:
- Building and maintaining a network of internal and external partners to accomplish Safety Policy & Processes oversight strategic goals
PV Processes oversight , providing input on PV regulations effective implementations into processes by ensuring commenting of corresponding Global SOPs
QPPV Office owned processes: ensuring QPPV office SOPs are kept up to date and reflect current regulatory requirement
Global Pharmacovigilance agreements (PVAs) content and oversight
Ensuring Global Pharmacovigilance Agreements reflect corresponding PV requirements, including QPPV function and oversight, as appropriate, and EU QPPV has the appropriate oversight on Global PV Agreements content and management process
Supporting ad hoc PVA related issues solving
Represent J&J in industry working groups and support industry association activities to influence global PV legislative environment and lead external collaborations (e.g. TransCelerate, …) to influence and shape PV and PV related legislative environment and drive commenting activities related to emerging legislation with potential PV implications to influence external environment through regulatory commenting
This position is responsible for internal and external collaborations to advance safety related topics Nd more specifically influence PV legislative environment, as well as leading monitoring, assessment and implementation of coming and new PV requirements at GMO and Janssen.
Additionally, the Head, Safety Policy & Processes oversight will:
- Proactively identify issues and problems, can identify and assess risk and the chances of success and offer solutions and recommendations
- Make complex decisions that resolve regulatory compliance or business issues and demonstrate acute understanding of the impact of decisions taken
- Interpret the applicability of PV regulatory guidance and processes to propose innovative solutions to compliance challenges and areas of PV Policy
- Have ability to work across different businesses and cultures on a worldwide basis to ensure global alignment and compliance with key contributors
- Understand partners/customer needs, be able to network building alliances and influence other groups
- Develop effective and highly communicative relationships across highly complex organizations of multifunctional personnel
- Exercise excellent judgment in assessing priorities and initiating projects
QPPV Office is a functional area within the Global Medical Safety. As such, this position will be an integral part of the QPPV Office and will interact with other team members to progress projects and programs and achieve results. The position will interact with senior leaders in GMS/Global Medical Organization, Janssen R&D and PV Policy Committee on important changes in PV legislative environment and cross-company collaborations/advancement in Safety Sciences.
As Senior Director, managerial responsibilities will be including:
- Management activities: Lead ‘defined function’ and other personnel, as assigned, including management of resource needs and resource allocation based on workload, recruitment, training and development as needed, identify key talent in the unit
- Enhancing performance and driving continued process improvements to the Safety Policy & Processes oversight unit
- Translating business vision and strategy into functional vision for staff
Qualifications
- Successful candidates will have a minimum of a bachelor's degree preferably in an engineering, science, health policy, health sciences or business field. Advanced Degree (e.g. PharmD, PhD, or MD) is strongly preferred
- Proven experience in pharmacovigilance or safety-related fields (e.g. Clinical Development, Medical Affairs)
- Successful experience in line management Strong critical thinking, analytical and problem-solving skills
- International experience is a plus
- Demonstrated networking skills - including ability to interact with internal staff, other company affiliates, as well as external clients/customers/service providers
- The Head, Safety Policy & Processes oversight will have excellent understanding of PV principles and processes, and to be skilled at assessing data and information, shaping messages, and developing and executing strategy.
- Demonstrated experience in communication, implementation of pivotal initiatives, and experience in the development and implementation of process changes and policy initiatives is required.
- Ability to facilitate J&J/GMS strategy, positions and policies effectively to promote J&J position in health leadership
- Results oriented with good listening, conflict resolution, negotiation, and interpersonal skills
- Languages: Excellent written and spoken English required. Additional language skills are a plus
- Travel up to 20% of time
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Primary Location
France-Haute-de-Seine-Issy Les Moulineaux-
Other Locations
United Kingdom, Netherlands, Switzerland, Belgium
Organization
Janssen Cilag S.A.S. (7825)
Job Function
R&D
Requisition ID
2005833281W