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Job Description
Responsibilities:
Takes care of maintaining valid registration licenses and submitting requests for new ones; keeps files and archives related to regulatory matters complete and up to date.
Ensures translations of product literature from English to Slovak language and vice versa.
Initiates the creation of new or modification of existing packaging materials as needed and actively participates in its approval.
Collects data on PV cases and quality issues and enters reports into the pharmacovigilance database (translated into English).
Acts as Qualified Person/Responsible Person for Veterinary Wholesale in accordance with local and EU law.
Reviews marketing promotional material for scientific content to ensure scientific accuracy and compliance with local regulations.
Monitors changes to local and EU laws related to regulatory matters and pharmacovigilance and initiates relevant processes at local and global levels as needed.
Creates and updates relevant Standard Operating Procedures as needed and ensures training of responsible persons.
Requirements:
Veterinary Medicine (graduated Veterinarian)- is a must
Proficient Slovak language due to daily work with Slovak language materials
Excellent in English, written and verbal, skill is needed to prepare translation of the English texts to national language
Preferred at least 1-year experience in regulatory affairs
Preferred experience in pharmacovigilance
Preferred experience in Good Distribution Practice and Quality Assurance
Familiar with local and EU legislation procedures at the level of regulatory affairs
Excellent planning and organization skills
We offer:
Life & Accident Insurance (Basic Life Insurance Permanent Disability – 12 monthly salaries, Death – 24 monthly salaries)
Pension Plan (AXA or ING, employer´s contribution: 2,5% of gross monthly salary)
Preventive Medical Exam (Onkologický ústav sv. Alžbety)
3 Sick Days per year
Current Contingent Workers apply
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
Job Posting End Date:08/07/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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