Pharmacovigilance Expert

Sopharma is the largest Bulgarian pharmaceutical company and a leading investor in the healthcare sector. With 2200+ employees, 11 manufacturing sites, and presence in 40+ markets, we stand for quality, reliability, stability, and transparency. What drives us is the care we put into improving lives - a dedication that has been bridging generations for over 90 years.

We are currently looking to recruit Pharmacovigilance Expert for our Regulatory Affairs and Pharmacovigilance Department to support and strengthen our drug safety activities across the products lifecycle and in accordance with GVP requirements.

Key Responsibilities:

• Manages and oversees PhV activities in compliance with applicable Global and local Pharmacovigilance legislation and company procedures.
• Performs case processing and medical review of ICSRs, ensuring timely submission of expedited safety reports to relevant Health Authorities.
• Manages signal detection and evaluation, including review of safety data and trends.
• Prepares and reviews aggregated safety reports (PSURs/PBRERs), RMPs and other regulatory safety documents.
• Conducts literature searches and assist with data entry, reconciliation, and quality control within safety databases and EudraVigilance.
• Supports PSMF maintenance and pharmacovigilance quality management, including improvement of SOPs, deviation and CAPA management, trainings.
• Participates in pharmacovigilance audits and Health Authorities inspections.
• Oversees pharmacovigilance activities performed by vendors or licensing partners, ensuring consistent safety data exchange processes and agreements.

Requirements:

• University degree in medical, natural sciences or pharmacy.
• Relevant knowledge of GVP requirements and international PhV regulations.
• Previous experience in ICSR management, signal detection, aggregate reporting and risk management.
• Fluent written and verbal English and/ or Russian.
• Result oriented attitude and outstanding organizational skills.
• Excellent business communication and presence.
• Advanced computer literacy and experience with safety databases/ systems.

The Company Offers:

• Opportunity to join a leading international business.
• An interesting, challenging job in a highly motivated and friendly team.
• Freedom to fully bring in your individual strengths and skills.
• Excellent work conditions.

If you are willing to build up your career with us, please send us your resume in English!

All applications will be treated strictly confidential. While we appreciate all applications, please, note that only short-listed candidates will be contacted.