J&J Family of Companies Local Safety Specialist in Beerse, Belgium
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.
Janssen Benelux is seeking to recruit a Local Safety Specialist (LSS) for the BeNeLux safety unit.
The Benelux Safety Team is part of the International Pharmacovigilance (IPV) organization and reports to the Area Safety Lead Mid-Size Markets. The LSS reports to the Benelux Safety Team Lead.
The primary responsibilities of the LSS include but are not limited to the below;
SAFETY MANAGEMENT & REPORTING
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.
PHARMACOVIGILANCE SERVICE PROVISION
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
CROSS-FUNCTIONAL COLLABORATION & SUPPORT
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
PROCESSES & REGULATIONS
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.
Essential knowledge & skills
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.
Limited travel (up to 15 %) required.
What’s in it for you…?
“Caring for the world, one person at a time…”
As an employee, we consider you as our most asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
Janssen Cilag N.V./S.A. (7025)
Drug & Product Safety Operations