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Country Safety Team Lead (BeNeLux)
Requisition ID: 1700204851W
‘Caring for the world, one person at a time’... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. 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.
Janssen is one of the world’s leading research-based pharmaceutical companies. In 1961, the company affiliated with the Johnson & Johnson Group, global market leader in healthcare products. The group has more than 265 operational companies in 60 countries today and more than 128,000 employees worldwide. Belgium is the largest Johnson & Johnson site outside the United States.
The CSTL has a reporting line into the International Pharmacovigilance organization via the Area Safety Team Lead and Cross Sector EMEA Safety Head.
The primary responsibilities of the CSTL include but are not limited to the below;
- Having line management responsibilities thereby managing, coaching and training the local safety staff of the BeNeLux safety unit.
- Ensuring that the pharmacovigilance for the local operating company product activities are managed in compliance with Belgium, The Netherlands and Luxembourg PV regulations. Moreover the CSTL is to ensure PV related compliance with local, regional or company policies/procedures and business partner commitments.
- Have an appropriate system of PV and risk management in place in order to assure appropriate oversight for products within its responsibility.
In maintaining the compliance of the pharmacovigilance system, activities under the direct conduct, management or supervision of the CSTL include but are not limited to the below.
- Processing, translations of individual case reports (ICSR) and submission of individual or aggregate reports to local Health Authorities
- Ensure compliance with the PV requirements within the framework of interventional, non-interventional or other research related activities
- Local literature search
- Supporting signal detection, the implementation of risk management plans and urgent safety restrictions, as required.
- Act as the local nominated contact for Pharmacovigilance as required by the local PV regulatory framework and as the single point of contact for the Global Medical Safety Organization.
- Perform contract review and maintain oversight to ensure safety reporting obligations are defined and integrated into case handling procedures as necessary
- Coordinate the provision of support for third party safety agreements with safety implications at the local level and ensure the safety agreement is implemented locally, as appropriate.
- Support PV audits, inspections and ensure audit and inspection readiness
- Collaborate with applicable internal functions (e.g. global and regional Regulatory Affairs, Quality) to address safety-related inquiries, relevant communication from the local regulatory authorities or support the review of study related documents (e.g. study protocol)
- Where applicable, support the QPPV or other functions in providing safety-related information or responses to the local Health authorities
- Ensure awareness on changes in local and regional PV relevant regulations which may have an impact on vigilance activities and responsibilities. Evaluate the impact on local processes and inform the appropriate global and regional groups (i.e. QPPV offices and IPV Regional Heads) of any changes to local PV relevant laws and regulations
- Ensure implementation of global and cross-pharma procedural documents as applicable.
- Strong people management skill-sets and experience
- Degrees of a medical nature (e.g. Medical doctor, pharmacist) or life sciences
- Sound knowledge of general medicine or pharmacy and clinical practice, or relevant scientific/medical field.
- Strong understanding of the relevant BeNeLux and regional (EMEA) PV regulatory frameworks
- Ability to establish and maintain constructive relationships within the organization and with local authorities.
- Fluency in the national language(s) of BeNeLux and English language is required.
- Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external customers.
- Medical or pharmaceutical sciences by preference, with proven expertise and experience in PV related regulations or guidelines and R&D processes.
- By preference a minimum of 3 + years pharmaceutical industry experience with at least 2 years in a product vigilance related role.
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Janssen Cilag N.V./S.A. (7025)