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Work with us

Job Offers

Pharmacovigilance Officer

The Pharmacovigilance Officer (PV Officer) will collect, register, and evaluate all safety information that emerges from PV activities during post-marketing uses of medicinal products.
Full Time

Madrid, Spain

Experience required:

At least 1 year at a similar position.

Duties required:

  • Act as a Qualified Person for PV/Local Contact Person for PV (QPPV/CPPV) or Deputy (as required), of marketed products, supporting the clients according to global/local regulation and specific needs
  • Management and follow-up of Adverse Events (AEs): report forms, assessment, causality, registration, Quality Control (QC) and submission activities meeting the set deadlines
  • Management and follow-up of the medical information enquiries received: answers, registration, QC and possible AEs detected, sending to the clients meeting the set deadlines
  • Perform internal training on PV for the company team and external trainings of the clients according to SOP
  • Notify the client and the Competent Authorities (CAs) of any reported Serious Adverse Event (SAE), meeting the requested due date
  • Ensure that all information related to product’s safety is notified to the CA.
  • Perform (as required) the literature research for the specific substances and trade names for the products included in PV agreements
  • Support the QPPV with the preparation and maintaining of the PV System Master File (PSMF)
  • Prepare the Risk Management Plan (RMP) for marketed products
  • Ensure 24/7 hours PV availability to the clients
  • Revise and update the PV calendar monthly for each product
  • Make PSURs when needed and support their submission to the CAs
  • Support the QPPV in maintenance of the EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) for the medicinal products of the clients
  • Give support to the QPPV about any Direct Healthcare Professional Communications (DHPCs) to be prepared and distributed in Spain
  • Support the QPPV in performing the European PV Regulatory Monitoring considering the PV regulations and the safety information published by EU RAs related to the products monitored for the clients
  • Perform the Spanish PV Regulatory Monitoring considering the PV regulations and the safety information published by the AEMPS related to the products monitored for the clients
  • Preparation of safety concerns documentation in relationship with Marketing Authorization (MA)
  • Application and renewals
  • Calculate the Key Performance Indicators (KPI) of the Department
  • Prepare and update the SOPs and working instructions of the clients if required
  • Prepare and maintain the PV SOPs, Manuals, Plans, Annexes and records of the Department
  • Maintain the PV archiving of the Department and complete the file forms to be checked by the QPPV/CPPV for each project
  • Revise the Safety Data Exchange Agreement (SDEA) for each client
  • Attend internal and external audits/inspections to the Department and support the preparation of the audit/inspection responses with the HeadPV/QPPV/CPPV and the QA department of the company
  • Support in the monthly reconciliation reports (when needed)
  • Support performing some administrative duties like service orders and the monthly invoicing when it is needed

Education and skills required:

  • Degree in Life Sciences or similar.
  • Specific education in PV (Master will be desirable).
  • Additional knowledge and/or experience in Vet PV: highly desirable.
  • Working knowledge of Microsoft Office package.
  • Organizational and teamwork skills
  • Knowledge of at least one PV Database
  • English level: fluent.

Dual position Clinical Trials Data Manager & Google Administrator

Management of data handling from the design of eCRFs, data cleaning, to the closure of the clinical trial databases. Management of documentation associated with clinical trial management. Administration of the data system, permissions, and security of the documentation and data management system. Use of Google Administrator applications for data security. Configuration of Google tools within the documentation and quality management system.
Full Time

Madrid, Spain

Experience required:

  • At least 1 to 3 years’ experience as Data Manager in clinical trials.
  • Training in data management and statistics applied to clinical trials or equivalent.
  • Experience in eCRFs such as ShareCRF, RedCap.
  • Use of tools to develop eCRFs.

Duties required:

  • To design eCRFs:
  • Will define variables and visits on paper CRF (starting from the protocol)
  • Will carry out programming, and subsequent configuration and management of eCRF tools and user access.
  • Carrying out the eCRF validation process (PQ validation).
  • Preparation of documents such as: Data Management Plan, Query Plan, eCRF Guide, periodic reports to stakeholders, etc.
  • Database management
  • Analysis and processing of variables Databases review and cleaning
  • Partial or total closure
  • Transfer to Sponsor
  • Managing access and permissions to devices and shared units on the cloud
  • Ensure the alignment of the cloud system with GXP requirements (Data Integrity; access control, traceability, and restriction; change control)
  • Research tasks for optimization and advanced use of Google Workspace in the company (in collaboration with the Quality Department), across all its applications (G Drive, G Forms, G Sites, etc.)
  • Providing User-level training for employees

Education and skills required:

  • Degree in Life Sciences or Equivalence as Medicine, Pharmacy, Chemistry or similar
  • Studies in Data Management and/or statistics applied to clinical trials or equivalent (Clinical Data Manager)
  • Experience in SaaS professional cooperative environments such as Google Workspace, participating in tasks related to the administration is high valued.
  • Computerized systems validations especially in GXP environments (applied to eCRFs) is high valuable.
  • Languages: Fluent Spanish and English, knowledge of other languages will be an asset.
  • Personal skills:
    • Proactive and very organized
    • Flexible, open-minded.
    • Ability to work in multidisciplinary and remote teams.
    • Ability to focus on multiple deliverables and protocols simultaneously.

CTA

A Clinical Trial Assistant (CTA) will manage administrative tasks throughout the life stages of a clinical trial, supporting the QF Local Study Team with the submission, collecting, listing, maintaining, tracking and updating (as corresponds) of trial related documentation; being a relevant liaison with other parties of the clinical study (Health Authorities, research sites, CRAs and Sponsor, when applicable).
Full Time

Madrid, Spain

Experience required:

At least, 1 year at similar position.

Duties required:

  • Supporting, the Local Study Team collecting and tracking the documents and data required for regulatory submissions (contracts, financial agreements, patient informed consent forms, insurance certificates).
  • Performing study submission to Health authorities, initial, amendments, notifications, etc.
  • Maintaining and updating of the Trial Master File and preparation for relevant QC checks when applicable
  • Tracking site budget related matters, including processing invoices, tracking payments and for scheduling meetings, updating Excel trackers, coordinating the translation of site documents.
  • Train CTA trainees, if applicable.

Education and skills required:

  • Postgraduate studies or course of Clinical Trial Assistant (or equivalent), ongoing or finished.
  • Good command of written English.
  • Excellent organizational and prioritization skills.
  • Knowledge of Microsoft Office programs.
  • Attention to detail and excellent oral and written communication skills.

Senior CRA

Participate in pre-trial procedures, archiving documents and correspondence, setting up and organizing clinical trial sites, perform on-site visits and training and mentoring of CRAs with less experience. Supporting activities to CTM regarding project management.
Full Time

Madrid, Spain

Experience required:

At least 1 year in a similar position.

Duties required:

  • Perform site selection, SIV, IMV and COV in clinical studies of new and established pharmaceuticals.
  • Responsible for support and management of sites to ensure that projects are conducted in accordance with protocol, applicable regulation, and the latest ICH guidelines.
  • Obtain, maintain and review applicable clinical documentation in a timely manner.
  • Prepare and attend investigator meetings.
  • Participate in hosting pertinent audits/inspections when necessary.
  • Training and mentoring of CRAs with less experience.
  • Eventual support in the writing of company procedures.

Education and skills required:

  • Degree in life sciences or equivalent.
  • Master of Clinical Trials Monitoring.
  • Proven track record as an accomplished CRA in IMP trials (at least 4 years).
  • English: Fluent spoken & written.
  • Excellent communication and time management skills to manage multiple projects at any one time.
  • Strong team member and understand the need for effective communication at all levels.
  • Effective relationship building with sponsors, sites and colleagues, as well as strong management skills.
  • Responsible person, able to work with autonomy, dynamic and well organized.
  • Must be able to travel in accordance with company and project requirements.

CRA

Participate in pre-trial procedures, archiving documents and correspondence, setting up and organizing clinical trial sites and perform on-site visits.
Full Time

Madrid, Spain

Experience required:

At least 1 year in a similar position.

Duties required:

  • Perform in site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation.
  • Support and management of the sites to ensure that projects are conducted in accordance with protocol, applicable regulation, and the latest ICH guidelines.
  • Managing progress by tracking case report form (CRF) completion and data query resolution.
  • Evaluating the quality and integrity of site practices – escalating quality issues as appropriate.
  • Cooperating and/or writing study plans and manuals.

Education and skills required:

  • Bachelor’s degree, or equivalent, in a scientific or healthcare discipline.
  • Master of Clinical Trials Monitoring.
  • Understanding of SOPs, WIs, EU, and local regulations as well as ICH GCP guidelines.
  • Good command of written and spoken English language.
  • Computer skills including use of Microsoft Word, Excel, and PowerPoint.
  • Willingness and ability to travel.
  • Responsible person, dynamic and organized, good team player.

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