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MSD Regulatory Affairs Pharmacovigilance Quality Assurance Specialist 
Slovakia, Region of Bratislava, Bratislava 
821900879

28.07.2024

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.