+46 8 791 66 40
Desirable qualifications and background
- Academic degree in natural science such as life sciences, pharmacy or nursing.
- At least 3 years of pharmacovigilance experience in the Pharmaceutical/CRO industry
- Strong knowledge of GCP/ICH Guidelines and other applicable regulatory requirements.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
- Good ability to express yourself both verbally and in writing.
- Good knowledge of spoken and written English.
- Good organizational skills.
- A service-minded approach
- Position may require 4-5 days/week travel both national and international.
- Valid driving license.
- Workplace at IRW’s or Sponsor’s office.
- Write detailed description of the pharmacovigilance system
- Collect and review Adverse Drug Reactions (ADR) /Adverse Events.
- Duplicate check and 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 (European countries and USA)
- 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 EudraVigilance Medicinal Product Dictionary
Archiving of pharmacovigilance documents
- Provide training for colleagues on pharmacovigilance, administrative, and company procedures and processes
- Demonstrate willingness to take on any level project activity consistent with current or past experience
- Participate in Audits and Inspections
- Assist with company’s quality control initiative
- Participate in company-required training/conference programs