Pharmacovigilance Officer (PVO) Sweden, København Denmark, Vantaa Finland, Norway,
Posted on : 10 July 2017
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 company 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
182 17 Danderyd Sweden1310 København K DenmarkRajatorpantie 41 01640 Vantaa FinlandNO 1366 Lysaker Norway
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