Sven Zielke

Patient Safety / Pharmakovigilanz Manager

Bochum, North Rhine-Westphalia, Germany

About

As a scientist, I am always driven by the curiosity to want to check events for correlation or causality. And as Pharmacovigilance Manger, I can use these skills to contribute to the safe use of medicines to allay patients' suffering and improve their quality of life. I am an experienced pharmacovigilance professional including 9 years of experience in different positions in pharmacovigilance. Furthermore, I have professional experience as Quality Manager as well as Data Protection Officer. As Pharmacovigilance Manager and Safety Specialist I was able to get to know different PV systems in different sized companies (from local affiliate to global level). In these positions, I have actively participated in establishment, maintenance, and continuous improvement of PV systems to meet the growing demands of developing new markets and integration of new products into existing systems. According to this, I am familiar with legal national and international PV regulations. I have hands-on experience in most pharmacovigilance tasks e.g., but not limited to, case processing, data base entry, signal detection and risk management activities, management of PVAs/SDEAs, third party qualification, (co-)auditing, preparation of and participation at inspections, CAPA management, etc. Additionally, through my professional experience as quality manager (certified), I am used to cover common QM-leaded tasks. Furthermore, I am very familiar with the processing of personal data, especially health data, based on my experience as data protection officer (certified).

Experience

  • Local Safety Officer Austria at UCB Deutschland
    Oct 2024 - Present · 1 yr 9 mos

  • Senior Drug Safety Manager at Dr. Haney Pharma GmbH
    Apr 2024 - Sep 2024 · 6 mos

    Bereitstellung von Dienstleistungen für die sichere Anwendung von Arzneimitteln (Bereitstellung von PV-Systemen, PV-Prozessen, Verantwortliche Positionen Stufenplanbeauftragte/EU-QPPV/ lokale PV Kontaktperson, Audits, ...

  • Pharmacovigilance Manager at Auf der Suche nach Herausforderungen
    Nov 2023 - Apr 2024 · 6 mos

    I am an experienced pharmacovigilance professional including 9 years of experience in different positions in pharmacovigilance. Furthermore, I have professional experience as Quality Manager as well as Data Protection Officer. As Pharmacovigilance Manager and Safety Specialist I was able to get to know different PV systems in different sized companies (from local affiliate to global level). In these positions, I have actively participated in establishment, maintenance, and continuous improvement of PV systems to meet the growing demands of developing new markets and integration of new products into existing systems. According to this, I am familiar with legal national and international PV regulations. I have hands-on experience in most pharmacovigilance tasks e.g., but not limited to, case processing, data base entry, signal detection and risk management activities, management of PVAs/SDEAs, third party qualification, (co-)auditing, preparation of and participation at inspections, CAPA management, etc. Additionally, through my professional experience as quality manager (certified), I am used to cover common QM-leaded tasks. Furthermore, I am very familiar with the processing of personal data, especially health data, based on my experience as data protection officer (certified).

  • Pharmakovigilanz Manager at MEDICE - The Health Family
    May 2023 - Nov 2023 · 7 mos

  • Safety Specialist at UCB
    Dec 2021 - May 2023 · 1 yr 6 mos