Pharmacovigilance specialist

Become a part of our team as a

Pharmacovigilance specialist

(Local Pharmacovigilance Responsible Person)

Wörwag Pharma is an international pharmaceutical company, operating in Bulgaria for over 30 years now. With their engagement and experience, our employees have made us what we are today: a successful, internationally active pharmaceutical company with over 1200 employees in more than 38 countries. As a family-owned company we develop, produce and distribute bio factors and generic products in few therapeutic areas – treatment of diabetes and its complications, cardio-vascular and neurologic diseases and pain relief. We are leader on Bulgarian market with products like Milgamma, Thiogamma, Magnerot and others.

Tasks & Responsibilities

• Act as Local Responsible Person for PV
• Maintain the local PV system aligned with GVP, company standards, and regulatory updates.
• Implement global/local SOPs and maintain PSMF contributions.
• Serve as 24/7 authority contact; handle inspections, audits, and queries.
• Oversee adverse event collection, processing, reporting, and local case management.
• Monitor literature, internet, and interactive digital media for ADRs/special situations;
• Identify and escalate safety concerns;
• Deliver PV training and ensure compliance
• Perform reconciliations, documentation, and archiving.
• Ensure PV review of medical inquiries and product safety/quality compliance.
• Coordinate PSUR requirements, timelines, and data inputs.

Requirements

• Higher education in natural sciences (recommended medical or pharmaceutical)
• Minimum 2-3 years of experience in PV
• Strong knowledge of EU and Bulgarian PV legislation and GVP modules
• Experience with ICSR processing.
• Familiarity with PSMF, PSURs, and RMPs
• Previous interaction with regulatory authorities is a strong advantage.
• Excellent organizational skills and attention to detail.
• Fluent English, corresponding to Level B2 or higher
• Strong analytical and problem-solving skills
• Ability to work independently and manage multiple tasks
• High level of integrity and compliance mindset

What we offer:

• Opportunity to join a well-established and developing pharmaceutical company with strong company values and team spirit;
• Dynamic environment with the opportunity to take on responsibility, to contribute experience and knowledge and to implement ideas;
• Opportunities for personal and professional development
• Motivating remuneration package in line with the market and individual performance, as well as additional benefits;

If you are ready to take on this challenging opportunity and step up in your future development, please apply by sending us your CV. Only shortlisted candidates will be approached.