Pharmacovigilance Associate - Pharmacovigilance Solutions

Pharmacovigilance Associate


KLIFO is looking for a talented and committed Pharmacovigilance Associate based in Denmark

KLIFO is expanding our office in Denmark and wants to engage an additional Pharmacovigilance Associate into a dynamic and experienced team within Pharmacovigilance Solutions. The person we want to engage like to work in an a consulting environment and has a positive, proactive, flexible, self-driven and self-confident personality. We can offer a highly flexible, free and trustful working climate with exciting customers and projects among competent colleagues where your knowledge, experience and contribution are valuable and highly appreciated.

The position:

The Pharmacovigilance Associate is responsible for collaboration with clients and execution of projects according to the clients expectations:

  • Single Adverse Event case handling including data entry, evaluation, assessment and writing of safety narratives
  • Monitoring of the pharmacovigilance mailbox
  • Handling of safety databases
  • Preparation of pharmacovigilance and safety documents; for example Safety Management Plans, PSURs, DSURs, and safety signal reports
  • Drive medical monitoring activities
  • Maintain pharmacovigilance system master files
  • Author and review of SOPs

Qualifications:

  • MSc/BSc in the life science field, nurse or holding a diploma within Pharmacovigilance
  • Preferably > 3 years of experience from a similar position in the pharmaceutical industry/Biotech/CRO
  • Knowledge og drug safety guidelines, terminology and processes
  • Experience with safety databases
  • Excellent communication skills in English both written and verbal
  • Experienced user of MS Office and good understanding of databases
  • Able to translate client´s needs into solid deliveries

We offer:

  • Work within different therapeutic areas and with tasks of varying complexity
  • Work with a heterogeneous client pool (pharmaceutical companies, stablished biotech, newly started biotech and academia)
  • Build international client relations
  • Use and elaborate your competences and experience
  • Work in an interactive, flexible and positive working environment

Location:

KLIFO has offices in Denmark, Germany, Sweden and the Netherlands. This position is located at our office in Glostrup, Denmark

Contact:

For more information, please contact Randi Rahbæk, Senior Clinical Director  at +45 4477 8704

Applications should be sent to: moc.ofilk@boj marked Pharmacovigilance Associate

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Deadline: Please reply as soon as possible. Recruitment interviews will be held on an ongoing basis.

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QA Officer - Quality Assurance Solutions

QA Officer


KLIFO is looking for a QA Officer for our Glostrup Office

Would you like to use your QA experience as QA Officer and support our highly skilled manufacturing department with a variety of quality support tasks?  And would you like to work for a small and very client-focused company?

At KLIFO, we’re looking for a new colleague to become part of our highly experienced Quality Assurance Team reporting to Anne Ploug Jørgensen, Senior Director Quality Assurance.

The position:

As QA Officer you will be working with a diversity of traditional QA tasks for our local production as batch review, deviations, complaints and CAPAs as well as writing of SOPs. e

Qualifications:

Preferable you are a pharmacist or have an education that makes you able to become a QP Delegate.
You must have at least one years’ experience with QA work or pharmaceutical manufacturing.

We offer:

As our new QA Officer you will:

  • Get the opportunity to bring all your pharmaceutical competences into play in a position with many different QA tasks
  • The opportunity to develop your skills within all aspects of traditional QA and QMS
  • Later on the possibility to become a Lead auditor can be an opportunity for the right candidate
  • Join an open, flexible and positive working environment with a high degree of influence and transparency
  • Collaborate with a team of dedicated and experienced colleagues

Location:

KLIFO has offices in Denmark, Germany, Sweden and the Netherlands. This position is located at our office in Glostrup, Denmark

Contact:

For more information, please contact Anne Ploug Jørgensen, Senior Director QA,  at +45 44 222 982

Applications should be sent to: moc.ofilk@boj marked QA Officer

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Deadline: Please reply as soon as possible. Recruitment interviews will be held on an ongoing basis.

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Proposal Manager - Clinical Operations Solutions

Proposal Manager


KLIFO is looking for an experienced and skilled Proposal Manager for one of our offices in Denmark, Sweden or Germany

KLIFO is expanding our services and would like to engage a new Proposal Manager into a dynamic and experienced team within Clinical Operations Solutions.

The person we want to engage like to work in a consulting environment and have a positive, proactive, flexible, self-driven and self-confident personality. We can offer a highly flexible, free and trustful working climate with exciting customers and projects among competent colleagues where your knowledge, experience and contribution are valuable and highly appreciated.

The position as Proposal Manager:

Acts as proposal and contract leader for COS projects (DK, GER, NL and SWE). The main focus of this position is to prepare and follow-up proposal and contractual documents including budget calculation and presentation, i.e.:

  • Leader of the proposal process in COS globally
  • Receives and reviews clinical Requests for Proposals (RFPs) to ensure full understanding of the client’s requirements
  • Prepares text, budget and cover letter for to accurately reflect services to be provided, client requirements and key selling points
  • Work with COS Management, Business Development and key appointed experts to understand proposal strategy and develop proposal response and costing
  • Leads proposal development meetings
  • Use the costing model to develop budget
  • Completes client bid grids
  • Obtains third party or other KLIFO department quotes
  • Assures accuracy, consistency and competitiveness of budget, text and attachments
  • Keeps Management and Business Development informed throughout the proposal development process
  • Interacts with clients during proposal preparation, justification meetings and in bid defence
  • Prepares rebids as requested by client
  • Leader of the contract process
  • Develops, negotiates and executes client contracts in collaboration with COS Management, Business Development, Finance and Legal
  • Prepares additional contractual content and documents for example payment schedules and changes in scope

The qualifications/skills of the Proposal Manager:

  • Business Development / Outsourcing / Contracts experience from CRO, Biotech or Pharma and a minimum of 3-4 years in a similar position
  • BSc/MSc in the life sciences field or related discipline
  • Knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Excellent communication skills (written and verbal) in English as well as in native language (if other than English)
  • Action oriented and strong ability to drive things forward
  • Strong planning and task management skills
  • Organizational agility
  • Analytical skills

We offer:

  • Work within different therapeutic areas and with tasks of varying complexity
  • Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia)
  • Build international client relations
  • Use and elaborate your competences and experience
  • Work in an interactive, flexible and positive working environment

Location:

KLIFO has offices in Denmark, Germany, Sweden and the Netherlands.

Contact:

For more information, please contact Vice President for COS, Klas Rådberg at +45 44 222 935

Applications should be sent to: moc.ofilk@boj marked Proposal Manager COS

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Deadline: 30 September, 2021 (although applications are reviewed on an ongoing basis)

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Medical Writer - Clinical Operations Solutions

Medical Writer


KLIFO is looking for a talented Medical Writer (DK, SE or DE)

KLIFO is expanding and wants to engage a Medical Writer into a dynamic and experienced team within Clinical Operations Solutions. The right candidate can be located in the Danish, Swedish or German office

The person we want to engage like to work in a consulting environment and have a positive, proactive, flexible, self-driven and self-confident personality. We can offer a highly flexible, free and trustful working climate with exciting customers and projects among competent colleagues where your knowledge, experience and contribution are valuable and highly appreciated.

The position as Medical Writer (MW):

The MW is responsible for creation of medical and scientific documents and the factual and formally correct display of scientific results and findings within clinical trials and non-interventional studies according to the FDA/EMA and ICH guidelines, i.e.:

  • Writing of clinical study protocols
  • Generation of clinical study reports
  • Generation of IBs and other documents related to the conduct of clinical trials and non-interventional studies
  • Generation of patient facing material, e.g. patient information
  • Support the project team in preparation and compilation of narrative safety reports
  • Advise the project team in preparation of study documents

The qualifications of the MW:

  • MSc in the life sciences field or related discipline, preferable with a PhD and a minimum of 3 years in a similar position in the pharmaceutical industry/CRO
  • Experience in medical writing, particularly in the creation of Clincial Study Protocols and Clinical Study Reports conforming to ICH-GCP
  • Good statistical understanding in the area of descriptive statistics
  • Ability to reproduce scientific data and complex issues accurately and in an understandable form
  • Ability to translate client’s needs into a solid project plan
  • Excellent communication skills (written and verbal)
    in English as well as in native language (if other than English)
  • Microsoft Office Skills

We offer:

  • Work within different therapeutic areas and with tasks of varying complexity
  • A heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia)
  • Build international client relations
  • Use and elaborate your competences and experience
  • Work in an interactive, flexible and positive working environment

Location:

KLIFO has offices in Denmark, Germany, Sweden and the Netherlands. This position can be based in Denmark, Sweden or Germany.

Contact:

For more information, please contact Team Manager Stefan Ingelsson at +45 9189 4818 or Director Jennie Wilborgsson at +45 9363 8820

Applications should be sent to: moc.ofilk@boj marked MW

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Deadline: 20 September, 2021 (although applications are reviewed on an ongoing basis)

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Senior Clinical Research Associate - Clinical Operations Solutions, Glostrup, Denmark

Senior Clinical Research Associate


KLIFO is looking for a talented and committed Senior Clinical Research Associate (CRA) for our Glostrup office

KLIFO is expanding our office in Denmark and wants to engage a Senior CRA into a dynamic and experienced team within Clinical Operations Solutions. The people we want to engage like to work in a consulting environment and have a positive, proactive, flexible, self-driven and self-confident personality. We can offer a highly flexible, free and trustful working climate with exciting customers and projects among competent colleagues where your knowledge, experience and contribution are valuable and highly appreciated.

The position as Senior CRA:

The Senior CRA is responsible for monitoring activities of trials across several sites and/or countries including pro-active site management and oversight:

  • Development of study specific plans in cooperation with Project Manager and sponsor
  • Prepare trial submission material for applications to Ethics Committee and review Regulatory Submission Packages
  • Performing feasibility and assessing suitability of clinical trial sites
  • Perform site initiation, monitoring and close-out visits
  • Participate in the Risk Based Quality Management process with focus on the monitoring strategy
  • Coordinate data cleaning activities in cooperation with data management
  • Training and supervision of CRAs in trial specific processes and perform co-monitoring visits
  • Function as Lead CRA if a trial has multiple sites including proactive site management and oversight

The qualifications of the Senior CRA:

  • Sc. in the life sciences field or related discipline and a minimum of 3-4 years in a similar position in the pharmaceutical industry/Biotech/CRO
  • Knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Willingness to travel
  • Excellent communication skills (written and verbal) in English
  • Experience with multi-country and multi-center trials
  • Ability to translate client’s needs into solid deliveries
  • Ability to work independently
  • Ability to supervise and coach non-senior personnel within the group

We offer:

  • Work within different therapeutic areas and with tasks of varying complexity
  • Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia)
  • Build international client relations
  • Use – and elaborate – your competences and experience
  • Work in an interactive, flexible and positive working environment

KLIFO has offices in Denmark, Germany, Sweden and the Netherlands. This position will be located at our office in Glostrup, Denmark.

Contact:

For more information, please contact Randi Rahbæk, Senior Director, at +45 44 778 704

Applications should be sent to: moc.ofilk@boj marked Senior CRA

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Deadline: 18 August, 2021 (although applications are reviewed on an ongoing basis)

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Clinical Supply Manager, Glostrup, Denmark

Clinical Supply Manager


KLIFO is looking for a Clinical Supply Manager for our Glostrup office

Would you like to use your solid experience within the pharmaceutical industry to join our highly skilled Clinical supply department as Clinical Supply Manager?
We are growing and we need more dedicated colleagues to help us maintain and further develop our high quality level.

The position:

As Clinical Supply Manager you will be working with a diversity of tasks from planning and coordinating clinical trials in close dialogue and cooperation with our clients, to preparation and approval of labels texts according to Annex 13, packaging materials, designs and blinding setups, coordinating return & destruction of IMP and cooperating with our distribution team in preparing distribution set ups.

As our Clinical Supply Manager you will also coordinate and collaborate with other CMO/CRO’s ensuring a highly qualified service level towards our clients.

Qualifications:

The ideal candidate is a person committed to create and deliver solutions that meet individual customer needs.
Also, the person must have an independent, positive, proactive and flexible personality.
Our candidate is experienced with GMP and experienced within the pharmaceutical industry

We offer:

As our new Clinical Supply Manager you will be part of an inspiring working environment in a growing company. You will work with exciting customers among competent colleagues where your knowledge, experience and contribution is highly valued. You will also get:

  • High job variation
  • High level of influence
  • Great social working environment and committed colleagues
  • A highly flexible, free and trustful culture

Location:

KLIFO has offices in Denmark, Germany, Sweden and the Netherlands. This position will be located at our office in Glostrup, Denmark.

Contact:

For more information, please contact Lotte Harreby, Director, at +45 44 222 969 or Pernille Smith, Team Manager, at +45 44 222 986

Applications should be sent to: moc.ofilk@boj marked Project Manager

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Deadline: 13 September 2021 (although applications are reviewed on an ongoing basis)

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Project Manager / Senior Project Manager - Clinical Operations Solutions, Glostrup, Denmark

Project Managers / Senior Project Managers


KLIFO is looking for talented and committed Project Managers / Senior Project Managers for our Glostrup office

KLIFO is expanding our office in Denmark and wants to engage Project Managers into a dynamic and experienced team within Clinical Operations Solutions. The people we want to engage like to work in a consulting environment and have a positive, proactive, flexible, self-driven and self-confident personality. We can offer a highly flexible, free and trustful working climate with exciting customers and projects among competent colleagues where your knowledge, experience and contribution are valuable and highly appreciated.

The position as Project Manager:

The Project Manager (PM) is responsible for the delivery of an agreed trial as defined in the trial outline/protocol, to the agreed quality, budget and timelines:

  • Lead the clinical trial team and coordinate and manage all activities related to clinical trials
  • Planning, delivery and management of clinical trial activities (start-up, operational conduct and closure) according to SOPs and a responsibility split with Sponsor
  • Liaison with clinical trial team members regarding trial design and protocol preparation and ensure the production of the final trial protocol
  • Lead the Risk Based Quality Management (RBQM) process including risk assessment and risk controls
  • Development of project plans for the conduct of the clinical trial.
  • Communicate timelines, identify milestones, handle trial budget and report progress for the clinical trials to sponsor and to COS management team

The qualifications of the Project Manager:

  • BSc/MSc in the life sciences field and a minimum of 3-4 years in a similar position in the pharmaceutical industry/BioTech/CRO
  • Solid experience within clinical trial management
  • Knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Ability to translate client’s needs into a solid project plan
  • Excellent communication skills (written and verbal) in English as well as in native language (if other than English)
  • Microsoft Office Skills

We offer:

  • Work within different therapeutic areas and with tasks of varying complexity
  • Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia)
  • Build international client relations
  • Use – and elaborate – your competences and experience
  • Work in an interactive, flexible and positive working environment

KLIFO has offices in Denmark, Germany, Sweden and the Netherlands. This position will be located at our office in Glostrup, Denmark.

Contact:

For more information, please contact Stefan Ingelsson, Team Manager, at +45 91 894 818 or Jennie Wilborgsson, Clinical Research Director, at +45 93 638 820

Applications should be sent to: moc.ofilk@boj marked Project Manager

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Deadline: 31 August, 2021 (although applications are reviewed on an ongoing basis)

View job post as a PDF.


Project Manager / Senior Project Manager - Clinical Operations Solutions, Glostrup, Denmark

Project Managers / Senior Project Managers


KLIFO is looking for talented and committed Project Managers / Senior Project Managers for our Glostrup office

KLIFO is expanding our office in Denmark and wants to engage Project Managers into a dynamic and experienced team within Clinical Operations Solutions. The people we want to engage like to work in a consulting environment and have a positive, proactive, flexible, self-driven and self-confident personality. We can offer a highly flexible, free and trustful working climate with exciting customers and projects among competent colleagues where your knowledge, experience and contribution are valuable and highly appreciated.

The position as Project Manager:

The Project Manager (PM) is responsible for the delivery of an agreed trial as defined in the trial outline/protocol, to the agreed quality, budget and timelines:

  • Lead the clinical trial team and coordinate and manage all activities related to clinical trials
  • Planning, delivery and management of clinical trial activities (start-up, operational conduct and closure) according to SOPs and a responsibility split with Sponsor
  • Liaison with clinical trial team members regarding trial design and protocol preparation and ensure the production of the final trial protocol
  • Lead the Risk Based Quality Management (RBQM) process including risk assessment and risk controls
  • Development of project plans for the conduct of the clinical trial.
  • Communicate timelines, identify milestones, handle trial budget and report progress for the clinical trials to sponsor and to COS management team

The qualifications of the Project Manager:

  • BSc/MSc in the life sciences field and a minimum of 3-4 years in a similar position in the pharmaceutical industry/BioTech/CRO
  • Solid experience within clinical trial management
  • Knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Ability to translate client’s needs into a solid project plan
  • Excellent communication skills (written and verbal) in English as well as in native language (if other than English)
  • Microsoft Office Skills

We offer:

  • Work within different therapeutic areas and with tasks of varying complexity
  • Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia)
  • Build international client relations
  • Use – and elaborate – your competences and experience
  • Work in an interactive, flexible and positive working environment

KLIFO has offices in Denmark, Germany, Sweden and the Netherlands. This position will be located at our office in Glostrup, Denmark.

Contact:

For more information, please contact Stefan Ingelsson, Team Manager, at +45 91 894 818 or Jennie Wilborgsson, Clinical Research Director, at +45 93 638 820

Applications should be sent to: moc.ofilk@boj marked Project Manager

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Deadline: 31 August, 2021 (although applications are reviewed on an ongoing basis)

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Finance Manager

Finance Manager


KLIFO is looking for a Finance Manager for our Glostrup office

KLIFO has grown significantly over the last years both in Denmark and through subsidiaries in Germany, Netherlands and Sweden. To support the growth, KLIFO is now looking for a Finance Manager, who can develop and professionalize accounting at local and group level.

The position is new and it gives you the opportunity to build and develop local and group Accounting in KLIFO.

You will have a team of two accountants in Denmark and you will work closely with the controller in Germany and the external accountants in Sweden and Netherlands.

KLIFO is a rapidly growing company, therefore it is important that you thrive in a growing organization and you are able to be hands-on and at the same time maintain the overview.

You report to KLIFO’s CFO and will collaborate and align with the controllers of the Service Areas. Together with your finance colleagues you prepare the reporting and develop finance related policies, processes and tools

Your primary tasks will be:

  • Daily management of the accounting department
  • Ensure correct processes and month-end closure
  • Consolidate KLIFO Group P&L and balance sheet on a monthly basis
  • Prepare monthly Cash-flow report and estimate
  • Prepare annual report
  • Develop Finance Policies and ensure implementation in subsidiaries
  • Participate in implementation of new finance systems

Qualifications:

  • You have a solid accounting and finance foundation including consolidation of foreign subsidiaries
  • A relevant education such as HD (R) or Cand.merc.aud with minimum 3-5 years relevant experience as either auditor or from similar position in a project driven company
  • You are self-driven and you know how to create motivation and good atmosphere in your department
  • You are professionally skilled and work naturally with optimizing/automating work processes
  • You can work independently, but are also a dedicated team player who values collaboration
  • You are an experienced user of Excel and preferable you have experience using Dynamics Nav
  • You are fluent in Danish and in English

We offer:

KLIFO offers a position in a growing company where you will have the opportunity to influence decisions and develop your competences in collaboration with dedicated colleagues.

Location:

Position is located at our office in Glostrup, Denmark.

Contact:

For more information, please contact CFO Michael Krak at 44 222 900

Applications should be sent to: moc.ofilk@boj marked Finance Manager

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Deadline: 18 August 2021

We review applications and invite for interviews on an ongoing basis.

 

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Business/Project Controller

Business/Project Controller


KLIFO has grown significantly over the last years both in Denmark and through subsidiaries in Germany, Netherlands and Sweden. To support the growth, KLIFO is now looking for a Business/Project controller, who can be a pro-active support for the management of 3 service areas

All service areas are well-established in Denmark and in the process of expanding the business in the other countries. You will work closely together with management and project managers in all countries.

The position includes many aspects and you thrive just as well with daily hands-on work as analysis on future business. You will spare on financial topics with management, prepare monthly reporting and take care of the monthly invoicing in collaboration with project managers.

You report to KLIFO’s CFO and you will work closely with management of the service areas. Further, you will have collaboration with the controllers working for the other service areas and with accounting. Together with your finance colleagues you prepare the reporting and develop finance related policies, processes and tools

Your primary tasks will be:

  • Daily financial sparring with service area management and project managers
  • In collaboration with management prepare budgets and estimates
  • Monthly reporting including analysis and comments
  • Monthly invoicing
  • Prepare analysis to support the yearly business plan
  • Financial sanity check of client contracts

Qualifications:

  • You have experience as controller in a project-based organisation
  • A relevant education such as cand.merc or HD
  • You thrive in a growing organisation
  • You are able to handle many informations, create relevant overviews and communicate clearly
  • You can work independently, but are also a dedicated team player who values collaboration
  • You are an experienced user of Excel and preferable you have experience using Dynamics Nav
  • You are fluent in Danish and in English

We offer:

KLIFO offers a position in a growing company where you will have the opportunity to influence decisions and develop your competences in collaboration with dedicated colleagues.

Location:

Position is located at our office in Glostrup, Denmark.

Contact:

For more information, please contact CFO Michael Krak at 44 222 900

Applications should be sent to: moc.ofilk@boj marked Business/Project Controller

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Deadline: 6 October 2021

We review applications and invite for interviews on an ongoing basis.

 

View job post as a PDF.