MSD Regulatory Affairs Pharmacovigilance Quality Assurance Specialist 

Slovakia, Region of Bratislava, Bratislava 

821900879

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.