About the role

Your responsibilities

• Maintaining the system for collecting, assessing, and submitting data on adverse reactions and lack of efficacy in Ukraine.
• Ensuring the implementation of necessary pharmacovigilance and product safety measures in accordance with national legislation, the corporate Vigilance Agreement, and Standard Operating Procedures (SOPs).
• Interaction with the national regulatory authority and Risk Management & Vigilance to ensure timely submission of pharmacovigilance reports, risk management plans, and other safety information regarding medicinal products.
• Implementing safety-related variations for medicinal products, and liaising with regulatory authorities regarding registration, re-registration, or safety amendments.
• Drafting texts for product labeling and instructions for the medical use of medicinal products in accordance with regulatory requirements.
• Reviewing and approving advertising and promotional materials for medicinal products in compliance with regulatory requirements.
• Participating in the approval process of color layouts (AWs) for the instructions accompanying the medicinal product, as well as reviewing and approving AWs of other packaging elements.
• Analyzing changes in Ukrainian legislation and corporate procedures concerning pharmacovigilance, medicinal products, medical devices, and cosmetics, and implementing these changes into practice.

The experience we're looking for

• Degree in pharmaceutical or medical field
• At least 2 years of experience in pharmacovigilance and regulatory affairs
• Experience in maintaining a pharmacovigilance system
• Fluent Ukrainian and
• Solid grasp of regulations, with a knack for interpreting their impact and implementing them innovatively.
• Proven communication skills, able to manage relationships with stakeholders and cross-functional teams.
• A record of delivering results and adapting to new information and challenges.

The skills for success

What we offer

Equality