Manager Patient Safety
il y a 3 semaines
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us as a Founder of our ‘new’ Sandoz
**The Manager Patient Safety (Belgium & Luxembourg) is responsible to**:
**Lead pharmacovigilance activities in the Sandoz affiliate **, in the context of the Sandoz Pharmacovigilance System, patient safety operating model, and associated quality system, to ensure that local safety procedures are comprehensive, effective, compliant and well embedded in the cross-functional and global-regional-local environment.
**Influence the affiliate organization **as a key member of the affiliate organization with high visibility, to promote a thorough understanding of the pharmacovigilance system, adherence to safety requirements for local activities.
**Ensure the seamless flow of safety relevant information **, within the affiliate, with local business partners and with regional hubs and 3rd party vendor in accordance with the Sandoz patient safety operating model.
**Maintain awareness on **safety profiles of Sandoz products **and provide safety expertise and support for all marketed and investigational products - drugs and combination products - to other functions in the affiliate.
**Establish or participate in oversight mechanisms **on safety activities **, specifically those outsourced to vendors on behalf of the affiliate (local activities, such as in patient-oriented programs as well as core safety activities, and core safety activities, such as case handling and periodic report generation).
**Participate in the maintenance of the local quality management system **, including training, records management, regulatory intelligence, audit and inspection readiness, in collaboration with local, regional and global functions, business partners and vendors.
**Your Key Responsibilities**:
Your responsibilities include, but not limited to:
- **Leadership**:
Build strong relationships with relevant functions in the affiliate organization (including but not limited to regulatory affairs, medical affairs, quality assurance, marketing and sales, clinical development and others), in collaboration with the Director Patient Safety HUB Europe and 3rd party vendors.
- **Communication flow**:
In collaboration with the Sandoz regional Hubs and the 3rd party vendor operational hubs, ensure that communication flows for safety processes including any **local sources of safety data **and **safety issues **are identified and implemented.
- **Single point of contact**:
As defined by local regulations act as the National/Local Qualified Person or Local Contact Person for Pharmacovigilance in the country(ies) and act as the single point of contact with the Local Health Authority. Be contactable on a 24 hours a day, 7 days a week.
- **Management of Safety Information**:
- Management of Adverse Events**:Ensure the local management of adverse event information, Identification of sources of adverse event information, Maintaining oversight on case content and reporting.
**- Management of Periodic reports**:planning and oversight.
**- Management of Local Literature in **collaboration with 3rd party vendor.
**- Support business in the set-up of programs **and any other activities that may elicit adverse event and other safety relevant.
- **Sandoz product safety profiles and related actions**:
- Health Authority Requests (and other externally generated signals)**:In collaboration with 3rd party vendor, Regulatory Affairs (RA) and other functions, ensure processes are in place to answer fully and promptly any safety related requests from Local Health Authorities.
- **Awareness of Sandoz product safety profiles **.
- **Risk Management**: Cooperation and oversight of the implementation of local RMP commitments and effectiveness checks. - Ensure readiness to implement ad hoc safety measures.
- **QMS and supporting processes**:
- Local Procedures**:Ensure the local Pharmacovigilance requirements are met. Where required, implement local procedures to supplement PS global procedures.
**- Trainings of **local internal and external stakeholders on pharmacovigilance obligations.
Monitor internal compliance for local processing and external compliance.
**- Audits and Inspections**:In cooperation with the 3rd party vendor, partner functions and management maintain audit/inspection readiness and manage local Pharmacovigilance audit/inspection.
**- Deviation and CAPA management**
**- PV Agreements**
**- Regulatory Intelligence **.
**- Local 24hr accessibilit
-
Health & Safety Manager
Il y a 2 mois
Vilvoorde, Belgique Goodman Temps pleinHealth & Safety Manager Vilvoorde Always wanted to challenge the obvious and make great things happen? At Goodman we create space for your greatness! Goodman Group (GMG:ASX) is a global real estate group, founded in 1999, with a focus on critical infrastructure. Our organization is a real estate company, acting as long-term investor, developer, fund...
-
Technical Manager Fire Safety/Electricity
il y a 3 jours
Vilvoorde, Flanders, Belgique Vinçotte Temps pleinParmi les principaux acteurs de son secteur en Belgique, Vinçotte se profile comme la référence dans les domaines de la qualité et la sécurité. Forts de nos 1 600 collaborateurs, nous contribuons chaque jour à la sécurité des personnes & des biens, à la qualité de la production & de la construction et à la fiabilité des équipements & des...
-
Technical Manager Fire Safety/Electricity
il y a 7 jours
Vilvoorde, Flanders, Belgique Vinçotte Temps pleinAls een van de belangrijkste spelers in zijn sector in België, is Vinçotte een referentie voor kwaliteit, veiligheid en milieu. Met 1.600 medewerkers dragen we dagelijks bij aan de veiligheid van mensen en gebouwen, de kwaliteit van productie en constructies en de betrouwbaarheid van apparatuur en installaties. Onze hoofdactiviteiten zijn inspectie,...
-
Health & Safety Manager
Il y a 6 mois
Vilvoorde, Belgique PB Leiner Temps plein**Bedrijfsomschrijving** PB Leiner is één van 's werelds grootste producenten van hoogwaardige gelatine en collageenpeptiden. Wij bedienen een groeiende markt in voeding, farma, gezondheidsvoeding en technische toepassingen. We streven er altijd naar om ‘The Clear Solution’ te zijn voor onze klanten. We spotten en benutten kansen voor hen, en proberen...
-
Technical Manager Fire Safety/Electricity
il y a 1 semaine
Vilvoorde, Belgique Vinçotte Temps pleinAls een van de belangrijkste spelers in zijn sector in België, is Vinçotte een referentie voor kwaliteit, veiligheid en milieu. Met 1.600 medewerkers dragen we dagelijks bij aan de veiligheid van mensen en gebouwen, de kwaliteit van productie en constructies en de betrouwbaarheid van apparatuur en installaties. Onze hoofdactiviteiten zijn inspectie,...
-
Technical Manager Fire Safety/Electricity
il y a 3 semaines
Vilvoorde, Belgique Vinçotte Temps pleinParmi les principaux acteurs de son secteur en Belgique, Vinçotte se profile comme la référence dans les domaines de la qualité et la sécurité. Forts de nos 1 600 collaborateurs, nous contribuons chaque jour à la sécurité des personnes & des biens, à la qualité de la production & de la construction et à la fiabilité des équipements & des...
-
Technical Manager Fire Safety/Electricity
il y a 4 semaines
Vilvoorde, Belgique Vinçotte Temps pleinAls een van de belangrijkste spelers in zijn sector in België, is Vinçotte een referentie voor kwaliteit, veiligheid en milieu. Met 1.600 medewerkers dragen we dagelijks bij aan de veiligheid van mensen en gebouwen, de kwaliteit van productie en constructies en de betrouwbaarheid van apparatuur en installaties. Onze hoofdactiviteiten zijn inspectie,...
-
Technical Manager Fire Safety/Electricity
il y a 3 semaines
Vilvoorde, Belgique Vinçotte Temps pleinParmi les principaux acteurs de son secteur en Belgique, Vinçotte se profile comme la référence dans les domaines de la qualité et la sécurité. Forts de nos 1 600 collaborateurs, nous contribuons chaque jour à la sécurité des personnes & des biens, à la qualité de la production & de la construction et à la fiabilité des équipements & des...
-
Quality Affiliate Manager
Il y a 6 mois
Vilvoorde, Belgique Astellas Temps plein**About Astellas**: At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and...
-
technical manager
il y a 7 jours
Vilvoorde, Flanders, Belgique Vinçotte Temps pleinAls een van de belangrijkste spelers in zijn sector in België, is Vinçotte een referentie voor kwaliteit, veiligheid en milieu. Met 1.600 medewerkers dragen we dagelijks bij aan de veiligheid van mensen en gebouwen, de kwaliteit van productie en constructies en de betrouwbaarheid van apparatuur en installaties. Onze hoofdactiviteiten zijn inspectie,...
-
Quality Affiliate Manager
Il y a 7 mois
Vilvoorde, Belgique Astellas Temps pleinAt 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...
-
Market Access Manager #s24
Il y a 3 mois
Vilvoorde, Belgique Sandoz Temps pleinSandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture...
-
Key Account Manager
Il y a 2 mois
Vilvoorde, Belgique Sandoz Temps pleinSandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture...
-
project manager
il y a 7 jours
Vilvoorde, Flanders, Belgique Vinçotte Temps pleinVinçotte is the market leader in Belgium for quality, safety and environmental services. We have built up our know-how and organization in both public and residential buildings, but we are also very active in the energy sector, including nuclear power. We are also particularly innovative when it comes to our customers in the petrochemical and pharmaceutical...
-
First Line Manager Cardio South Belgium
Il y a 7 mois
Vilvoorde, Belgique Novartis Temps plein387067BR **First Line Manager Cardio South Belgium (French)**: Belgium **About the role** The FLM Cardio South will be responsible for driving the sales operations plan and for achieving agreed sales and broader performance targets for their part of the organization/specific product area. The FLM will develop an effective sales team through training and...
-
Regulatory Affairs Officer
Il y a 2 mois
Vilvoorde, Belgique Sandoz Temps pleinSandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture...
-
Data Insights
Il y a 7 mois
Vilvoorde, Belgique Novartis Temps plein393744BR **Data Insights & Business Planning Manager**: Belgium **About the role** **Location: Belgium - Vilvoorde** The Data Insights & Business Planning Manager is responsible to proactively support priority brands with early databased and actionable insights and analytics to accelerate adoption of NVS brands making an impact for the product...
-
Service Manager Benelux
Il y a 6 mois
Vilvoorde, Belgique Sebia Temps pleinCDI - 1 F/H Service Manager Benelux SEBIA - Leader mondial du diagnostic biomédical Basé à 1800 Vilvoorde - Belgique **POSITION TITLE** **SERVICE MANAGER Benelux** **SCOPE** - Plans, directs and controls all the activities of the Service department, aimed at satisfying customers and solving their technical needs, in line with company strategy and in...
-
Field Project Associate
Il y a 2 mois
Vilvoorde, Belgique Novartis Temps plein**Summary**: Field Project Managers are responsible for defining the scope of projects, creating detailed work plans, and determining the resources required to complete projects. They also oversee the quality and consistency of materials, manage parts inventory accuracy, and ensure compliance with safety standards and regulations **About the Role**: **Key...
-
Country Quality Manager
Il y a 2 mois
Vilvoorde, Belgique Sandoz Temps pleinSandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture...
