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Clinical Research Associate

Reporting to: Nordic Director, Clinical Operations

Desirable qualifications and background
  • Academic degree in natural science such as life sciences
  • Experience from pharmaceutical, biotechnology or medical device industries
  • Experience from Clinical Research Organizations (CRO)
  • Good ability to express yourself both verbally and in writing
  • Good knowledge of spoken and written English
  • Good organizational skills
  • A service-minded approach
  • Ability to prioritize and handle several tasks simultaneously
  • Valid driving license

 

Principal duties

  • Prepare and complete applications to the regulatory authorities and ethic committees
  • Prepare and conduct pre-study activities, site selection and initiation visits, routine monitoring and close out visits
  • Negotiate contracts with sites, local/central laboratories, pharmacies etc.
  • Manage assigned sites throughout the study to ensure site compliance, adequate enrolment, and understanding of study requirements
  • Participate in Audits and Inspections
  • Assist in data validation and clean file procedures
  • Planning and participating at Investigators meeting
  • Responsible for final archiving of study documents in-house and on-site

 

Clinical Research Manager

Reporting to: Nordic Director, Clinical Operations

Desirable qualifications and background
  • Academic degree in natural science such as medicine, pharmacist biomedicine or similar
  • Experience from pharmaceutical, biotechnology or medical device industries
  • Experience from Clinical Research Organizations (CRO)
  • A well developed understanding for customer care and business development
  • Good ability to express yourself both verbally and in writing
  • Good knowledge of spoken and written English
  • Good organizational skills
  • A service-minded approach
  • Ability to prioritize and handle several tasks simultaneously

 

Principal duties
  • Planning, coordination and execution of projects
  • Lead the study team and ensure that study deliverables are met
  • Managing project budget
  • Assist the study team during audits and inspections
  • Prepare and complete applications to the regulatory authorities and ethic committees
  • Prepare and conduct pre-study activities, selection and initiation visits, routine monitoring and close out visits
  • Selecting and negotiating contracts with sites, local/central laboratories, pharmacies etc.
  • Training of staff
  • Planning, participating and leading Investigators meeting
  • Writing and preparing the Clinical Study Documentation

 

Pharmacovigilance Associate

Reporting to: Pharmacovigilance Manager

Desirable qualifications and background
  • Bachelor or Master’s degree in life sciences, pharmacy, nursing or RN
  • At least 1 year of pharmacovigilance experience in the pharmaceutical/CRO industry
  • Strong knowledge of ICH guidelines and other applicable regulatory requirements.
  • Good ability to express yourself both verbally and in writing
  • Good knowledge of spoken and written English
  • Good organizational skills
  • A service-minded approach
  • Ability to prioritize and handle several tasks simultaneously
  • Strong interpersonal skills and the ability to build relationships both internally and externally

 

Principal duties
  • Collect and review Adverse Drug Reactions(ADR) / Adverse events
  • Database entry of ADR and SAE in the internal safety database
  • MedDRA coding
  • Report safety information to Regulatory Authorities.
  • Worldwide literature search
  • Draft Periodic Safety Update Reports (PSUR) and Annual Safety Reports
  • Support Clients in the EudraVigilance registration process
  • Eudravigilance testing
  • Register products in the EudraVigilance Medicinal Product Dictionary
  • Archiving of Pharmacovigilance documents

 

Pharmacovigilance Officer

Reporting to: Pharmacovigilance Manager

Desirable qualifications and background
  • Bachelor or Master’s degree in life sciences, pharmacy, nursing or RN
  • At least 3 years of pharmacovigilance experience in the pharmaceutical/CRO industry
  • Strong knowledge of ICH guidelines and other applicable regulatory requirements.
  • Good ability to express yourself both verbally and in writing
  • Good knowledge of spoken and written English
  • Good organizational skills
  • Experience of mentoring junior Pharmacovigilance personnel
  • Ability to prioritize and handle several tasks simultaneously
  • Strong interpersonal skills and the ability to build relationships both internally and externally

 

Principal duties
  • Collect and review Adverse Drug Reactions(ADR) / Adverse events
  • Write detailed description of the pharmacovigilance system
  • Database entry of ADR and SAE in the internal safety database
  • MedDRA coding
  • Seriousness, expectedness and causality assessment
  • QC of database entry
  • Report safety information to Regulatory Authorities.
  • Worldwide literature search
  • Draft Periodic Safety Update Reports (PSUR) and Annual Safety Reports
  • Support Clients in the EudraVigilance registration process
  • Eudravigilance testing
  • Register products in the EudraVigilance Medicinal Product Dictionary
  • Archiving of Pharmacovigilance documents
  • Provide training for colleagues on pharmacovigilance, administrative, and company procedures and processes.