Global pharmacovigilance position as the first contact point for all Affiliate Drug Safety Officers
(Leiden, The Netherlands)
Offer
Position
In the role as Affiliate Support Manager you will be responsible for the day-to-day interactions with and guidance of the Affiliate Drug Safety Officers (DSOs) to ensure all affiliate local pharmacovigilance systems, processes and procedures are compliant, efficient and in line with global/regional regulatory requirements, policies and procedures. You are going to serve as a first point of contact for all global DSOs, monitor affiliate performance, train affiliate staff, ensure audit and inspection readiness of affiliates, and identify, develop, and implement process improvements. Other tasks are ensuring training requirements for DSOs are kept up to date, managing projects and working together with cross-functional teams.
Profile
Organisation
The organisation is an international pharmaceutical organisation that has been operating in at least forty countries across Europe, the Middle East and Africa. They operate on a global level and most teams have a global focus. They have everything in house from research, development, manufacturing and warehousing to sales and marketing. It is their hope to change tomorrow’s world and to improve the lives of individuals by providing innovative medicines in areas of health, where there is an urgent need for better treatments. The organisation is clearly focused on bringing high-quality medicines to the market to reach their goals. Wouldn`t it be lovely to join them in their journey? At this moment they are open to meet an enthusiastic candidate for a temporary position as Affiliate Support Manager at their office in Leiden.
Response
Interested? Please send your resume and motivational letter by e-mail, with reference to DT/21-038, to Sandra van Putten: info@derksenderks.nl. For further information, please call Sandra van Putten at number +31 (0)33 472 80 87.
An individual assessment may be part of the selection procedure.
Our client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.
Who are we?
SentinelOne is shaping the future of endpoint security through its unified, converged platform that automatically prevents, detects, and responds to threats in real-time. Our unique approach is based on deep inspection of all system processes combined with innovative machine learning to quickly isolate malicious behaviors, protecting devices against advanced, targeted threats in real time.
What are we looking for?
The Learning and Development Director is a new role at SentinelOne which will be focused on building out a learning and development function for the entire organization globally. In a true start-up fashion, you will be responsible for both building the Learning strategy for the organization, driving best practice models and building the yearly plan as well as implementing and driving this to execution across the global organization. Therefore, we are looking for a high functioning individual who wants ownership while enjoying the challenge of building from scratch and being Hands-On in every way. The ideal candidate is one that thrives in ambiguity and fast paced environments and has the drive to work with multiple stakeholders both internally and externally to the org. to shape and build this function, making it an inherent part of SentinelOne Culture.
What will you do?
What skills and experience should you bring?
Why us?
You will work on real-world problems and make an impact by protecting our customers from cyber threats. You will join a cutting-edge project and will be able to influence the architecture, design and structure of our core platform. You will tackle extraordinary challenges and work with the very BEST in the industry.
Who are we?
SentinelOne is shaping the future of endpoint security through its unified, converged platform that automatically prevents, detects, and responds to threats in real-time. Our unique approach is based on deep inspection of all system processes combined with innovative machine learning to quickly isolate malicious behaviors, protecting devices against advanced, targeted threats in real time.
What are we looking for?
We are looking for a People Operations Specialist to join our team in our office in Amsterdam!
The People Operations Team is dynamic and challenging! We are a team that goes the extra mile and are dedicated to the work we do. We are always willing to help each other and communicate across different time zones in order to maintain our excellent working relationships. We prioritize communicating effectively in order to achieve optimum results. We are constantly striving for efficiency and are improving our processes and are keen to maximize all ideas in order to add value to the service we deliver. Overall, if you are proactive, knowledge seeking, have an eye for detail, a positive approach and willing to develop yourself then please read more.
You are responsible for administrative and daily operational tasks within the People Operations department.
What will you do?
What skills and experience should you bring?
Please note: this role is currently based Working From Home due to the ongoing Covid-19 Pandemic, however Netherlands based candidates are strongly preferred
Why us?
You will work on real-world problems and make an impact by protecting our customers from cyber threats. You will join a cutting-edge project and will be able to influence the architecture, design and structure of our core platform. You will tackle extraordinary challenges and work with the very BEST in the industry.
Who are we?
SentinelOne is shaping the future of endpoint security through its unified, converged platform that automatically prevents, detects, and responds to threats in real-time. Our unique approach is based on deep inspection of all system processes combined with innovative machine learning to quickly isolate malicious behaviors, protecting devices against advanced, targeted threats in real time.
What are we looking for?
SentinelOne’s global Talent Acquisition team's mission is to attract and empower people to do their best work and enable our hyper-growth trajectory. As a member of the Talent Acquisition leadership team, the Manager International Talent Acquisition will work closely with our Global Talent Acquisition and People Operations teams and stakeholders across the business to drive strategic growth in our international markets. You will be responsible for managing a team of recruiters and partnering with stakeholders to achieve hiring targets and execute on a recruiting strategy that sustains a diverse pool of talent through remarkably inclusive processes.This role will report directly to the VP of Global Talent Acquisition.
What will you do?
What skills and experience should you bring?
Why us?
You will work on real-world problems and make an impact by protecting our customers from cyber threats. You will join a cutting-edge project and will be able to influence the architecture, design and structure of our core platform. You will tackle extraordinary challenges and work with the very BEST in the industry.
Do you want to work for a fast growing, sparkling company? Keep on reading!
Sodastream is looking for an ambitious, highly driven and result-oriented Quality Supervisor for the Netherlands Logistics Center (NLC). NLC tripled in size in the past three years, with currently +/- 600 employees. In addition, we continue to grow!
In this position, you will be mainly focusing on managing and mentoring the team of Quality Inspectors. As the Quality Supervisor, you will also manage and implement a company’s quality assurance and control systems to ensure proper execution of products and customer satisfaction every time. As the Supervisor Quality, you report directly to the Quality and Health Manager & Head of NDT.
Your experience, broad perspective and excellent collaboration and management skills will enable you to be highly contributing to a strong and winning team!
Job description
Requirements:
At SodaStream, we are on a mission with a purpose: saving the environment by reducing single-use plastic waste. Every SodaStream bottle replaces thousands of single-use plastic bottles.
SodaStream enables consumers to easily transform ordinary tap water into sparkling water and flavoured sparkling water in seconds. By making ordinary water fun and exciting to drink, SodaStream helps consumers drink more water. SodaStream offers a highly differentiated and innovative solution to consumers of bottled and canned carbonated soft drinks.
What SodaStream has to offer?
SodaStream is a growing company and there are plenty of opportunities to grow with us. We offer you a fun, versatile and vibrant work environment in which you can adequately challenge and develop yourself. In addition, you will work in a fresh and open team, with lots of freedom and responsibilities in your work.
Are you interested and do you want to know more about SodaStream? Take a look at our website www.sodastream.nl
Job Summary (Primary function)
The focus of this role is to provide QP certification for release of Investigational Medicinal Products (IMP) into the EU.
Job responsibilities may extend to QP certification of commercial products in EU. Qualified Person is responsible for final certification/release of pharmaceutical Products for distribution in EU.
As a member of Incyte Global Quality, QP develops and maintains a strong collaboration with external partners and Incyte cross-functional teams to support implementation of Incyte Quality Initiatives and process improvements.
Essential Functions of the Job (Key responsibilities)
• EU/EEA IMP Qualified Person responsibilities include:
• Batch release and certification of IMP to be used in EU clinical trials to ensure IMP and its manufacturers comply with the EU Directives and applicable Annexes, Product Specification File and Clinical Trial Applications
o Maintenance of Product Specification File
o Providing QP GMP declarations in support of importation of Medicinal Product into EU
o Review of IMP deviations, complaints and change controls
• Batch release and certification of commercial product for EU distribution in accordance with EU Directives and applicable Annexes
• Ensures inspection readiness for regulatory inspections including hosting audits, management of inspections/rooms and responses to regulatory agency observations
• Perform GMP/GDP audits and Mock PAIs
• Responsible for maintaining Incyte GMP Licenses and GMP/GDP activities for medicinal products in EU
• Support withdrawal of IMPs
• Negotiate QA agreements
• Represent Incyte Global QA in cross-functional project team meetings
• Collaborate with Regulatory Affairs, Clinical Operations, Global Product and Process Development (Biologics and Small Molecule) to support regulatory submissions and Incyte GMP operations
• Collaborate with external partners QA, Responsible Persons (RPs) and QPs
• Review regulatory submission documents such as INDs/IMPDs as well as Incyte’s responses to Health Authorities requests and/or questions
• Participate in develop, implementation and maintenance of Incyte's Quality Management Systems
• Develop, review and approve standard operating procedures
Qualifications (Minimal acceptable level of education, work experience, and competency)
Must be fully qualified QP with experience of final certification/release within the EU/EEA. Good knowledge of Quality management (compliance, CAPA, continuous improvement) and international operations. Knowledge of EU regulatory requirements for small molecule and biological products are essential for this role. The ideal person will have the experience and the confidence to interact with Regulatory Authorities.
• Graduate, preferably in Chemistry, Pharmacy or Biological Science;
• Wide range of technical knowledge and experience within the pharmaceutical industry;
• Substantial previous Quality Assurance experience;
• Excellent scientific and technical knowledge;
• Is multi-skilled across a number of areas and has developed specialist expertise relevant to function;
• Up to date knowledge of cGMP, cGDP regulations;
• Team player and ability to work with remote teams;
• English fluency written and spoken (the company language);
• Strong verbal and written communication skills with well-structured communication and presentation ability;
• Strong interpersonal skills;
• Ability to travel 15-20% or more as needed.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
We Respect Your Privacy
Learn more at: http://www.incyte.com/privacy-policy
The Incyte hiring organisation processes your personal data to manage your job application in order to enter into an employment contract with you if you are the successful candidate.
You have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority.
Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights
We Respect Your Privacy
Learn more at: http://www.incyte.com/privacy-policy
The Incyte hiring organisation processes your personal data to manage your job application in order to enter into an employment contract with you if you are the successful candidate.
You have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority.
Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.
Job Summary (Primary function)
The focus of this role is to provide QP certification for release of Investigational Medicinal Products (IMP) into the EU.
Job responsibilities may extend to QP certification of commercial products in EU. Qualified Person is responsible for final certification/release of pharmaceutical Products for distribution in EU.
As a member of Incyte Global Quality, QP develops and maintains a strong collaboration with external partners and Incyte cross-functional teams to support implementation of Incyte Quality Initiatives and process improvements.
Essential Functions of the Job (Key responsibilities)
EU/EEA IMP Qualified Person responsibilities include:
Batch release and certification of IMP to be used in EU clinical trials to ensure IMP and its manufacturers comply with the EU Directives and applicable Annexes, Product Specification File and Clinical Trial Applications
o Maintenance of Product Specification File
o Providing QP GMP declarations in support of importation of Medicinal Product into EU
o Review of IMP deviations, complaints and change controls
Batch release and certification of commercial product for EU distribution in accordance with EU Directives and applicable Annexes
Ensures inspection readiness for regulatory inspections including hosting audits, management of inspections/rooms and responses to regulatory agency observations
Perform GMP/GDP audits and Mock PAIs
Responsible for maintaining Incyte GMP Licenses and GMP/GDP activities for medicinal products in EU
Support withdrawal of IMPs
Negotiate QA agreements
Represent Incyte Global QA in cross-functional project team meetings
Collaborate with Regulatory Affairs, Clinical Operations, Global Product and Process Development (Biologics and Small Molecule) to support regulatory submissions and Incyte GMP operations
Collaborate with external partners QA, Responsible Persons (RPs) and QPs
Review regulatory submission documents such as INDs/IMPDs as well as Incyte s responses to Health Authorities requests and/or questions
Participate in develop, implementation and maintenance of Incyte's Quality Management Systems
Develop, review and approve standard operating procedures
Qualifications (Minimal acceptable level of education, work experience, and competency)
Must be fully qualified QP with experience of final certification/release within the EU/EEA. Good knowledge of Quality management (compliance, CAPA, continuous improvement) and international operations. Knowledge of EU regulatory requirements for small molecule and biological products are essential for this role. The ideal person will have the experience and the confidence to interact with Regulatory Authorities.
Graduate, preferably in Chemistry, Pharmacy or Biological Science;
Wide range of technical knowledge and experience within the pharmaceutical industry;
Substantial previous Quality Assurance experience;
Excellent scientific and technical knowledge;
Is multi-skilled across a number of areas and has developed specialist expertise relevant to function;
Up to date knowledge of cGMP, cGDP regulations;
Team player and ability to work with remote teams;
English fluency written and spoken (the company language);
Strong verbal and written communication skills with well-structured communication and presentation ability;
Strong interpersonal skills;
Ability to travel 15-20% or more as needed.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
We Respect Your Privacy
Learn more at: http://www.incyte.com/privacy-policy
The Incyte hiring organisation processes your personal data to manage your job application in order to enter into an employment contract with you if you are the successful candidate.
You have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte s data protection officer, and your supervisory authority.
Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights
We Respect Your Privacy
Learn more at: http://www.incyte.com/privacy-policy
The Incyte hiring organisation processes your personal data to manage your job application in order to enter into an employment contract with you if you are the successful candidate.
You have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte s data protection officer, and your supervisory authority.
Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.
About Us:
SentinelOne was formed by an elite team of cyber security and defense experts from IBM, Intel, Check Point, Cylance, McAfee, and Palo Alto Networks. SentinelOne is shaping the future of endpoint security through its unified, converged platform that automatically prevents, detects, and responds to threats in real-time. Our unique approach is based on deep inspection of all system processes combined with innovative machine learning to quickly isolate malicious behaviours, protecting devices against advanced, targeted threats in real time.
Our company is built upon a foundation of team-players with innovative problem solving skills. We operate with the utmost integrity to represent the SentinelOne brand and support the 'good' within the cyber community. As we enter our next phase of hyper-growth, we're looking for people that will go the extra mile and join in our passion for building a bigger and better SentinelOne. If you are enthusiastic about cybersecurity and have a growth mentality, we would love to speak with you about joining our team!
What you will do?
We are looking for a Business Development Representative to act as the liaison between our Marketing and Sales teams. Your role will be to seek new business opportunities by contacting and developing relationships with potential customers.
To be successful in this role, you should have previous experience developing leads from marketing campaigns and meeting sales quotas. You will use your communication skills to cultivate strong relationships with customers, from first contact until you close the deal. You will also ensure proper after-sales service. If you are motivated and results-driven, and enjoy working in a team environment, we’d like to meet you. Ultimately, you will boost sales and contribute to our long-term business growth.
What experience and skills you should bring?
About Us:
SentinelOne was formed by an elite team of cyber security and defense experts from IBM, Intel, Check Point, Cylance, McAfee, and Palo Alto Networks. SentinelOne is shaping the future of endpoint security through its unified, converged platform that automatically prevents, detects, and responds to threats in real-time. Our unique approach is based on deep inspection of all system processes combined with innovative machine learning to quickly isolate malicious behaviours, protecting devices against advanced, targeted threats in real time.
Our company is built upon a foundation of team-players with innovative problem solving skills. We operate with the utmost integrity to represent the SentinelOne brand and support the 'good' within the cyber community. As we enter our next phase of hyper-growth, we're looking for people that will go the extra mile and join in our passion for building a bigger and better SentinelOne. If you are enthusiastic about cybersecurity and have a growth mentality, we would love to speak with you about joining our team!
What you will do?
We are looking for a Business Development Representative to act as the liaison between our Marketing and Sales teams. Your role will be to seek new business opportunities by contacting and developing relationships with potential customers.
To be successful in this role, you should have previous experience developing leads from marketing campaigns and meeting sales quotas. You will use your communication skills to cultivate strong relationships with customers, from first contact until you close the deal. You will also ensure proper after-sales service. If you are motivated and results-driven, and enjoy working in a team environment, we’d like to meet you. Ultimately, you will boost sales and contribute to our long-term business growth.
What experience and skills you should bring?
Type functie
Contractpartij, Fulltime
Geplaatst op
8 dagen geleden