Regulatory Affairs, Pharmacovigilance and Quality Assurance Specialist, Animal Health

Job Description

The position is related to veterinary medicinal products/Animal Health Business.

The Local Regulatory Affairs, Pharmacovigilance and Quality Assurance Specialist provides support, control and communication around veterinary medicinal products marketing authorizations (MA) and is responsible for Regulatory Affairs, Pharmacovigilance, Clinical Trials and Quality Assurance topics and processes, acts in a business-oriented way in terms of Regulatory Affairs during product development, as well as to get the best-authorized profile in order to introduce the product in the market in the shortest period.

In the field of pharmacovigilance is supporting all pharmacovigilance (PV) activities for our company's products. This includes management of the day-to-day adverse events as well as the development/update/implementation/training on standard operational procedures (SOP).

In addition, supports SOP on market support studies as well as the approval process of marketing and sales activities.

Main responsibilities:

• Keep files and archives related to Regulatory Affairs complete and updated.
• Establishe and update the relevant Standard Operating Procedures (SOP) to secure the current internal and external requirements on Regulatory Affair of the organization are compliant and implemented in requested time-lines.
• Provide regulatory representation and support for internal and external audits related to regulatory affairs field.
• Actively support translation of product literature to local language.
• Manage packing material requests, development, and approval.
• Assist in organization and oversee field trials for new products.
• Oversee of the pharmacovigilance data quality and information collection process.
• Enter reports to pharmacovigilance database (translated to English language) and process related data and documents in accordance to actual requirements.
• Develop and adapt applicable local procedures including training of personnel, documentation of the training process and process implementation.
• Ensure adequate support to other functions to enable compliance in areas related to regulatory, such as review of promotional material, customer presentations incl. social media.
• Give strategic regulatory advice or feedback to maximize best positioning of products and company business.

Skills Required:

• Proficient in native language due to daily work with native language materials (Slovak)
• 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 communication skills
• Excellent teamwork
• High level of diplomacy
• Meticulous
• Excellent planning and organization skills
• Open for changes
• Competent use of MS Office
• Flexibility in working hours i.e. being available for emergencies by either mobile phone, office or home telephone, email or fax outside of office hours.

Professional Competencies

• Project Management- Applying
• Productive Communication - Applying
• Problem Solving - Applying

Core Commercial Competencies

• Customer engagement - Applying
• Product knowledge and portfolio management - Applying
• Regulatory and compliance knowledge – Applying

PV Intelligence

• Knowledge of pharmacovigilance systems & requirements - Applying
• Knowledge of local country(ies) industry code(s) of practice – Applying
• Knowledge of pharmacovigilance principles, concepts, practices & standards - Applying
• In depth knowledge of the local country(ies) pharmacovigilance regulations & obligations - Applying

Other competencies

• Slovak language - Slovak native speaker
• English language - Advanced

Company offers:

We will provide to you all kind of trainings and will support your development!

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

If you want to:

• Assist in trials of new and existing products
• Join a multi-award-winning leading biopharmaceutical company
• Develop your career in our Animal Health division

Apply today!

On this position you will get opportunity to provide support, control, and communication around veterinary medicinal products marketing authorizations (MA) and is responsible for Regulatory Affairs, Pharmacovigilance, Clinical Trials and Quality Assurance topics.

Employee Status:
Regular

Percentage of travel
Up to 20%

Alternative location/sites
Hybrid/Office/Flexible/Home Office

Requisition ID: R227696