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URGENT: Clinical Safety Specialist, Maastricht

URGENT: Clinical Safety Specialist, Maastricht

Solliciteer direct
Opleidingsniveau: HBO Dienstverband: Vast Salaris: 2500 - 3500

Over de functie

As a clinical safety specialist you will work with other members of the MCO Clinical Safety team located around the world, Chinical Operations, Data Management, Quality Assurance and Regulatory Affairs to manage death and adverse event reporting in compliance with applicable regulatory standards and internal requirements.

Main responsibilities:

  • Review and triaging clinical trial deaths and adverse events including serious adverse events
  • Conduct Case Management in the Clinical Safety Database
  • Interact with investigational sites and field monitors to obtain additional pertinent information as indicated
  • Work with the clinical project team to ensure consistency in the assessment, recording and coding of clinical safety events
  • Work with Regulatory Affairs, Clinical Operations and Field Assurance to ensure timely reporting including expedited and annual reporting and other documents as needed
  • Ensures appropriate distribution and notification to appropriate personnel, partners, and clinical centers for protocols
  • Liaison for safety-related questions
  • Write Clinical Safety plan for assigned protocols
  • Assist with preparation of assigned section of safety reports for annual reports, clinical study reports, investigator brochure updates, and other documents as required
  • Collaborate with data management and other departments on the development of case report forms, study specific safety reports and other study specifc forms
  • Assist with the writing of safety sections of clinical protocols and may present safety monitoring at investigator meetings

Over het bedrijf

A large global multinational in the South of Holland.
 

Functie-eisen

For this position in Maastricht we're looking for a proffesional with good written, oral and interpersonal communication skills including knowledge of medical terminology.

  • Bachelor's degree 
  • 2 years safety experience 
  • Proficient with MS Office products, word processing, spreadsheets ect.
  • High attention to detail and accuracy and ability to manage multiple tasks
  • Good prioritization and organizational skills and excellent problem solving skills
  • Works effectively on cross-functinal teams

Arbeidsvoorwaarden

We offer you a professional, international, dynamical and high quality working environment, where personal development is stimulated and personal initiatives are encouraged. Your development plan will challenge you to further develop your personal skills and competencies, to build your career within our global organization.

  • Startdate: a.s.a.p.
  • Gross salary: €2900 - €3500 a month (40-hour work week). The salary depends on your age and years of experience in a simular role.
  • 8% holiday payment and 24 holidays, based on worked hours
  • Travel expenses of €0.19 cent pro km.

Contactinformatie

If you feel the Clinical Safety Specialist is of interest and it falls within your skills set, then please feel free to start your application by applying below. For further questions please contact Jacky Timmermans - Schmeits via jacky.schmeits@experis.nl or 06-46928761

Samenvatting

Geplaatst:13-10-2017Salaris:2500 - 3500
Specialisme:OverigOpleidingsniveau:HBO
Locatie:MaastrichtErvaring:Tot 3 jaar
Branche:Techniek/industrieDienstverband:Vast
Geplaatst:13-10-2017
Salaris:2500 - 3500
Specialisme:Overig
Opleidingsniveau:HBO
Locatie:Maastricht
Ervaring:Tot 3 jaar
Branche:Techniek/industrie
Dienstverband:Vast

Sollicitatieprocedure

Solliciteer op deze functie door hierboven op 'Solliciteer direct' te klikken. In ons sollicitatieproces is een cv verplicht maar een motivatiebrief is niet nodig.

Over Experis


Experis is onderdeel van ManpowerGroup. We bemiddelen tussen organisaties en professionals in vaste en interimbanen. Wij hebben de overtuiging dat plezier in het werk en werken vanuit persoonlijke drijfveren, leidt tot succes. Experis verbindt de ambitie van werkgevers met de talenten van professionals. Als deze samenkomen, behalen we samen een optimaal resultaat. Dit doen we al meer dan 30 jaar met veel plezier, succes en toewijding.

Experis. A different kind of talent company.