Mateusz Gajowniczek - Pharmacovigilance for Clinical Trials & Client Quality Manager Post-Marketing

Gdańsk, Poland

Experience

Jul 2021 - Present

4 years 7 months

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.

Nov 2017 - Jun 2021

3 years 8 months

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.

Mar 2015 - Oct 2017

2 years 8 months

Drug Safety Specialist

INC Research

May 2014 - Mar 2015

11 months

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.

May 2011 - May 2014

3 years 1 month

Pharmacist

PPH Puri-Pharma Sp. z.o.o.

Delivered medicinal products.
Provided pharmaceutical healthcare.
Prepared prescription drugs.
Administered e-pharmacy webpage.

Apr 2009 - Apr 2011

2 years 1 month

Pharmacist

Pharmacies

Delivered medicinal products.
Provided pharmaceutical healthcare.

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

English

Native

Polish

Native

German

Elementary

Education

Oct 2008 - Jun 2009

Medical University of Warsaw

Methodology of Clinical Researches, post-graduate · Methodology of Clinical Researches · Warsaw, Poland

Oct 2003 - Jun 2009

Medical University of Gdańsk

Pharmacy · Pharmacy · Gdańsk, Poland

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Experience

Pharmacovigilance for Clinical Trials & Client Quality Manager Post-Marketing

PrimeVigilance Ltd. (Ergomed Group)

Quality Assurance Specialist - Corporate B2B Team

Polpharma S.A.

Drug Safety Specialist

INC Research

Safety Data Specialist

MSD (Merck)

Pharmacist

PPH Puri-Pharma Sp. z.o.o.

Pharmacist

Pharmacies

Summary

Skills

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

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