Drug Safety Officer – Bulgaria

3-5 years

Not Disclosed

Bulgaria Remote

10 Feb. 13, 2025

Job Description

Job Type: Part Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description:

Drug Safety Officer (Freelancer)

Location: Sofia, Bulgaria (Part-time)
Company: Excelya (Contract Research Organization)

Company Overview:

Excelya is a leading CRO headquartered in Paris, founded in 2014. The company has a team of 900+ experts offering trial solutions across various therapeutic areas. Excelya is dedicated to advancing healthcare and research, with a goal to become the clinical research leader in Europe.

What We Offer:

Excelya fosters a stimulating professional environment that encourages personal, intellectual, and operational participation. As an Excelyate, team members will have the opportunity to develop their talents, express their full potential, and contribute to impactful projects.

Main Responsibilities

Collaboration and Regulatory Compliance:

Maintain a functional connection with the EEA Qualified Person for Pharmacovigilance (QPPV) by participating in regular Local Safety Officer (LSO) meetings.
Implement and maintain a pharmacovigilance system for client products authorized in the territory, ensuring compliance with regulatory and company requirements.
Maintain oversight of local deliverables delegated to service providers.

Quality Management and Safety Monitoring:

Maintain the quality management system related to pharmacovigilance, including the management of Standard Operating Procedures (SOPs), Associated Instructions (AIs), and other documents (e.g., forms, templates).
Perform regular gap analysis to ensure alignment with global SOPs.
Ensure timely management of deviations and risk mitigation by defining appropriate Corrective and Preventive Actions (CAPAs) and conducting ongoing trend analysis.

Vendor Management and Regulatory Intelligence:

Assess the capability and capacity of vendors for conducting critical pharmacovigilance tasks.
Support qualification audits and ensure compliance with regulatory requirements.
Stay updated on emerging regulatory changes and communicate such updates to corporate teams and local stakeholders.

Product Safety and Risk Management:

Proactively identify product safety risks and escalate safety issues to Safety Leads when appropriate.
Coordinate effective safety communication to Health Authorities (HAs), Healthcare Professionals (HCPs), and patients.
Ensure audit and inspection readiness for relevant local departments, in collaboration with corporate Patient Safety and Quality Assurance.
Act as the local Subject Matter Expert (SME) on product safety, contributing to product lifecycle activities, labelling reviews, and Risk Management Plans.

Education & Qualifications:

Bachelor’s degree in Life Sciences (e.g., physician, pharmacist, nurse) or relevant medical-scientific background (e.g., PhD/Master’s in biological sciences).
3-5 years of proven experience in pharmacovigilance.
Expert knowledge of regulatory requirements in pharmacovigilance.
Scientific background in Central Nervous System or immunology therapeutic areas is preferred.

Skills & Competencies:

Strong interpersonal skills, especially in individual leadership and adaptability.
Ability to lead, motivate, and influence in matrix organizations.
High level of integrity and honesty, able to inspire teams and others.
Excellent communication skills (oral and written) in English and Bulgarian.

Additional Information:

Role offers an opportunity for freelance work on a part-time basis.
The position involves collaborating with local and global teams to ensure pharmacovigilance and regulatory compliance across the assigned territory.

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