Mateusz Gajowniczek
Pharmacovigilance for Clinical Trials & Client Quality Manager Post-Marketing
Experience
Pharmacovigilance for Clinical Trials & Client Quality Manager Post-Marketing
PrimeVigilance Ltd. (Ergomed Group)
- Provide comprehensive PV QA/QM support for major global clients.
- Develop and maintain Quality Management Plans, project-specific training plans, and training matrices.
- Host client and regulatory audits, ensuring continuous inspection readiness.
- Oversee quality events, deviations, CAPAs, including trend analyses of quality metrics and ICSR errors.
- Manage system access control, resource qualification, CV/JD verification, and onboarding plans.
- Conduct regulatory intelligence ensuring alignment of project processes with global PV regulations.
- Ensure business continuity planning for project activities and PV systems.
- Contribute to PSMF maintenance and updates, ensuring timely inclusion of quality metrics, audit outcomes, procedural changes, and project-specific PV activities in alignment with regulatory expectations and client requirements.
Quality Assurance Specialist - Corporate B2B Team
Polpharma S.A.
- Managed deviations, OOS/OOE, change controls, CAPAs, and PQRs ensuring full GMP compliance.
- Negotiated and maintained quality agreements with external partners and manufacturers.
- Ensured marketing authorization compliance prior to product launch for out-licensed products.
- Supported audits and inspections, preparing evidence and leading cross-functional responses.
- Collaborated with RA, QC, Legal, Sales, and Marketing to maintain product quality and resolve urgent dossier-related issues.
- Provided oversight for external manufacturing, contract manufacturing, out-licensing, and quality documentation updates.
Drug Safety Specialist
INC Research
Safety Data Specialist
MSD (Merck)
- Processed ICSRs including triage, data entry, coding, quality control, and submissions for clinical trial and post-marketing cases.
- Handled EDC cases, spontaneous reports, solicited reports, literature cases, line listings, and medical record reviews.
- Performed reconciliation of investigational safety reports (OTC and prescription).
- Collaborated with international teams within Merck’s global data management center.
- Performed case reconciliation between safety and clinical systems and resolved mismatches in coordination with data management.
Pharmacist
PPH Puri-Pharma Sp. z.o.o.
- Delivered medicinal products.
- Provided pharmaceutical healthcare.
- Prepared prescription drugs.
- Administered e-pharmacy webpage.
Pharmacist
Pharmacies
- Delivered medicinal products.
- Provided pharmaceutical healthcare.
Industries Experience
See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.
Experienced in Pharmaceutical (17 years) and Healthcare (4.5 years).
Business Areas Experience
The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.
Experienced in Quality Assurance (12 years), Customer Service (5 years), Information Technology (3 years), and Operations (1 year).
Summary
Quality and Pharmacovigilance professional with 11+ years of experience across CROs and pharmaceutical companies. Strong expertise in PV, QA, QM, and GVP/GCP/GMP compliance within both post-marketing and clinical trial settings. Experienced in audit hosting, inspection readiness, ICSR management, and quality oversight of global projects. Recognized for structured problem-solving, cross-functional communication, and ensuring regulatory compliance for high-impact clients.
Skills
Pharmacovigilance For Clinical Trials & Post-marketing
Quality Assurance/ Quality Management
Safety Data Evaluation, Interpretation
Medical-scientific Writing
Regulatory Intelligence
Project Management & Cross-functional Leadership
Audit/inspection Readiness & Hosting
Quality Management Systems (Capa, Deviations, Kpis)
Risk Management & Issue Escalation
Pv Systems & Compliance Monitoring
Tasks Prioritization
Time Management
Teamwork
Leadership
Effective Communication
Critical Thinking
Argus Safety
Aris Global/lifesphere
Veeva Vault
Mastercontrol
Pph Puri-pharma Sp. Z.o.o.
Trackwise
Cornerstone Lms
Sharepoint
Power Bi
Languages
Education
Medical University of Warsaw
Methodology of Clinical Researches, post-graduate · Methodology of Clinical Researches · Warsaw, Poland
Medical University of Gdańsk
Pharmacy · Pharmacy · Gdańsk, Poland
Profile
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