URGENT: Clinical Safety Specialist, Maastricht | Maastricht | Fulltime | Manpower Vacaturenr: 37966470

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Over deze vacature

Deze vacature is in beheer van Experis, onderdeel van ManpowerGroup. De sollicitatie zal daarom plaatsvinden op www.experis.nl.

URGENT: Clinical Safety Specialist, Maastricht

Publicatiedatum: 18 oktober 2017
Regio: Limburg
Opleidingsniveau: HBO
Vakgebied: Logistiek
Aantal uren per week: 40
Full time/Part time: Fulltime
Client: Vertrouwelijk
Salarisindicatie: Loon per maand
€ 2500 - 3500 per maand € 14,45 - 20,23 per uur
Vacaturenummer: IGB-147056280

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

Over deze vacature

Deze vacature is in beheer van Experis, onderdeel van ManpowerGroup. De sollicitatie zal daarom plaatsvinden op www.experis.nl.

URGENT: Clinical Safety Specialist, Maastricht