Regulatory Affairs, Pharmacovigilance and Quality
**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
**Search Firm Representatives Please Read Carefully**
**Employee Status**:
Regular
**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Remote
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Job Posting End Date**:
11/5/2024
**Requisition ID**:R320167
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Zajímavé nabídky práce v okolí:
Práce Regulatory Affairs, Pharmacovigilance and Quality: Často kladené otázky
👉 V jakém městě se nabízí nabídka práce Regulatory Affairs, Pharmacovigilance and Quality?
Práce je nabízena v lokalitě Praha.
👉 Jaká firma nabírá na tuto pozici?
Tato nabídka práce je do firmy MSD.