Local Safety Officer
2 semanas atrás
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Primary responsibility
Cross Sector IPV Case Management Specialist is to:
- Ensuring Individual Case Safety Report (ICSR) case processing and related activities are carried out to enable compliance with applicable regulatory requirements, company procedures, at a local/regional level or global level, and in compliance with provisions of PV agreements with business partners.
- The role holder may be expected to support and ensure case management and related activities for other countries within the EMEA Region (centralized case management) are carried out in a timely manner.
As applicable, the responsibilities described below may account for cross-country collaborations
INBOUND & OUTBOUND ICSR CASE MANAGEMENT- Receipt, assessment and processing of incoming safety information from multiple sources, both internal and external to the Company.- Enter relevant/required safety data into the Global Inbound Receipt System (GIRS) from spontaneous, clinical trials and other solicited sources.- Provision of safety information/acknowledgements to marketing partners/other third-party partners/Global Medical Safety within the internal and contractual timelines.- Data entry for complex cases- Performing follow-up for requesting additional information from multiple sources.- Assist in the quality review of data captured in the GIRS as applicable- Verify and ensure translation of safety information, if applicable.- Continual monitoring, assessing the reportability of ICSRs due for regulatory reporting, and submitting to respective Competent Authorities (CAs) / Business Partners (BPs), as applicable.- Enable mechanisms to support LSO oversight for case management activities as applicable. e.g. escalation non-conformance in a timely manner.- Liaise with applicable stakeholder to support case processing requirements for Medical device vigilance, and/or cosmetovigilance (as applicable).
AGGREGATE REPORTING- Ensure timely submission of aggregate safety reports (e.g. DSUR, PSUR etc. applicable) to applicable health authorities, in collaboration with local medical safety input (as applicable).
COMPLIANCE MONITORING- Ensure accurate and timely documentation of deviations to process/timelines, including root cause analysis and documentation of Corrective and Preventive Actions (CAPAs) as applicable.- Support LSO in review of new/revised PV regulations, evaluation of the impact on local processes and notification of appropriate global and regional
AUDIT / INSPECTION PREPARATION AND SUPPORT- Represent IPV Case management or support the LSO, in matters pertaining to audit or inspection preparation or conduct.
Education, Skills and Other Requirements:
- minimum 3-4 years of relevant pv experience.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our
Privacy Statement
.
-
Local Safety Officer Portugal
Há 3 dias
Lisboa, Portugal UCB Tempo inteiro**Make your mark for patients** We are looking for a **Local Safety Officer** to join us in our **Patient Safety **team, based in our offices in **Lisbon, Portugal** **About the role** - Accountable for ensuring Pharmacovigilance systems, operations and procedures are in place within the local organization for all territories assigned to the Affiliate -...
-
Local Safety Officer Portugal
2 semanas atrás
Lisboa, Lisboa, Portugal UCB Tempo inteiroMake your mark for patientsWe are looking for a Local Safety Officer to join us in our Patient Safety team, based in our offices in Lisbon, PortugalAbout the role Accountable for ensuring Pharmacovigilance systems, operations and procedures are in place within the local organization for all territories assigned to the Affiliate Primary contact for...
-
Local Safety Officer
2 semanas atrás
Lisboa, Lisboa, Portugal Fortrea Tempo inteiroAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Safety Officer
Há 6 dias
Lisboa, Lisboa, Portugal Hi Fly Tempo inteiroHI FLY is a leading widebody aircraft wet lease specialist operating worldwide, with an Airbus fleet. The wet lease business market is very demanding, and airlines are increasingly opting for wet lease solutions as they are found to be reliable, safe, and efficient. For that reason, Hi Fly fleet is steadily growing with new widebody additions in the coming...
-
Medical Safety Officer, Established Products
2 semanas atrás
Lisboa, Lisboa, Portugal Johnson & Johnson Tempo inteiroJob Description - Medical Safety Officer, Established Products W) Description Johnson & Johnson, is recruiting for an Medical Safety Officer, Established Products to be located in Lisbon, Portugal. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented,...
-
Senior Regulatory Affairs
4 semanas atrás
Lisboa, Portugal Humana Portugal Tempo inteiroA bene farmacêutica, é uma sucursal portuguesa da empresa alemã bene-Arzneimittel GmbH, que distribui os seus produtos em Portugal há mais de 60 anos, com uma dinâmica cada vez mais crescente tanto no mercado farmacêutico português como de exportação. Procura integrar na sua equipa um Senior Regulatory Affairs & Local Safety Officer. Sobre a...
-
Senior Regulatory Affairs
4 semanas atrás
Lisboa, Portugal Grabjobs Portugal Tempo inteiroA bene farmacêutica, é uma sucursal portuguesa da empresa alemã bene-Arzneimittel GmbH, que distribui os seus produtos em Portugal há mais de 60 anos, com uma dinâmica cada vez mais crescente tanto no mercado farmacêutico português como de exportação. Procura integrar na sua equipa um Senior Regulatory Affairs & Local Safety Officer. Sobre a...
-
Medical Safety Officer, Established Products
1 semana atrás
Lisboa, Portugal Johnson & Johnson Tempo inteiro.Johnson & Johnson, is recruiting for an Medical Safety Officer, Established Products to be located in Lisbon, Portugal. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and...
-
Medical Safety Officer, Established Products
3 semanas atrás
Lisboa, Portugal Johnson & Johnson Tempo inteiroJohnson & Johnson, is recruiting for an Medical Safety Officer, Established Products to be located in Lisbon, Portugal. For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a...
-
Medical Safety Officer, Established Products
2 semanas atrás
Lisboa, Lisboa, Portugal Johnson & Johnson Tempo inteiroJohnson & Johnson, is recruiting for an Medical Safety Officer, Established Products to be located in Lisbon, Portugal.For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a...
-
Project Officer For Port State Control And Ship Safety
2 semanas atrás
Lisboa, Lisboa, Portugal Union for the Mediterranean Tempo inteiroProject Officer for Port State Control and Ship Safety European Maritime Safety Agency (EMSA) JOB DESCRIPTION General conditions for the secondment:This call for application is open to experts working for intergovernmental organisations (IGOs) or Government or State Departments in the EU Member States, Norway or Iceland.The secondment of an SNE by an...
-
Medical Safety Officer, Established Products
2 semanas atrás
Lisboa, Lisboa, Portugal Johnson & Johnson Tempo inteiroJohnson & Johnson, is recruiting for an Medical Safety Officer, Established Products to be located in Lisbon, Portugal.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions...
-
Medical Safety Officer, Established Products
2 semanas atrás
Lisboa, Lisboa, Portugal Johnson & Johnson Tempo inteiroJob Description - Medical Safety Officer, Established Products W)DescriptionJohnson & Johnson, is recruiting for an Medical Safety Officer, Established Products to be located in Lisbon, Portugal. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented,...
-
Safety Officer para Portugal
4 semanas atrás
Lisboa, Lisboa, Portugal GROUNDLINK HOLDING Tempo inteiroPROCURAMOSColaborador/a com o seguinte perfil:Conhecimento do Sistema de Gestão de Segurança (preferencial)Fluência em português, castelhano e inglêsCapacidade de trabalho em equipa, foco no cliente, independência e cumprimento de padrões elevados.Capacidade para trabalhar rapidamente e com um cronograma apertadoDisponibilidade para viajar consoante...
-
Logistics Officer
2 semanas atrás
Lisboa, Lisboa, Portugal Randstad II - Prestação de Serviços, Limitada Tempo inteiroWe are currently looking for a Logistics Officer for an international property management organization.Responsabilidades chave ⦁Coordinate transportation activities, including route planning, carrier selection, and cost optimization for the timely delivery of goods.⦁Ensure compliance with local and international regulations and industry standards,...
-
Senior Scientist, Safety Analysis Scientist
2 semanas atrás
Lisboa, Lisboa, Portugal Johnson and Johnson Tempo inteiroSenior Scientist, Safety Analysis Scientist Lisboa Senior Scientist, Safety Analysis ScientistLisboa Lisbon, Lisbon, Portugal Essential Job Duties and Responsibilities The Senior Scientist Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned products.The Senior Scientist SAS, in partnership with the...
-
Local Compliance Officer
4 semanas atrás
Lisboa, Portugal DLL Tempo inteiro**Local Compliance Officer** Reporting to General Manager and European Compliance Officer, the purpose of this function is to execute the compliance cycle for DLL which includes risk assessments, monitoring actions, incident handling, reporting and advise. Key compliance themes are AML, reporting and liaising with the Regulator, Anti-Corruption, Data...
-
Project Officer For Port State Control And Ship Safety
4 semanas atrás
Lisboa, Portugal Union For The Mediterranean Tempo inteiroProject Officer for Port State Control and Ship SafetyEuropean Maritime Safety Agency (EMSA) JOB DESCRIPTION General conditions for the secondment: This call for application is open to experts working for intergovernmental organisations (IGOs) or Government or State Departments in the EU Member States, Norway or Iceland. The secondment of an SNE by an...
-
Project Officer For Port State Control And Ship Safety
2 semanas atrás
Lisboa, Lisboa, Portugal Union For The Mediterranean Tempo inteiroProject Officer for Port State Control and Ship SafetyEuropean Maritime Safety Agency (EMSA) JOB DESCRIPTION General conditions for the secondment:This call for application is open to experts working for intergovernmental organisations (IGOs) or Government or State Departments in the EU Member States, Norway or Iceland.The secondment of an SNE by an employer...
-
Logistics Officer
2 semanas atrás
Lisboa, Lisboa, Portugal Randstad Ii - Prestação De Serviços, Limitada Tempo inteiroWe are currently looking for a Logistics Officer for an international property management organization.responsabilidades chave?Coordinate transportation activities, including route planning, carrier selection, and cost optimization for the timely delivery of goods.?Ensure compliance with local and international regulations and industry standards, including...