Małgorzata Siwek

Pharmacovigilance (PV) Team Leader in Poland Pharmacovigilance Data Management Center (DMC) a part of Merck's Global DMC network.

PV Review Process Leader (since February 2014).
PV Case Processing Leader (May 2013 to January 2014).
PV Intake Process Leader (February 2013 to November 2013).

- Coordinate local team of case processors and reviewers
- Act as an expert resource
- Ensuring team member complaince and quality
- Ensure alignment of processes and procedures with other Data Management Centers (worldwide)
- Perform training activities as needed
- Perform mentoring activities for new staff
- Perform quality review of reports from clinical trials (EDCs) and post marketing sources (spontaneous AE reporting)
- Actively participate in cross DMCs meetings (worldwide)

Perform data entry of all adverse experience information received and release to HQ through internal data base within the timeframe on the basis of standard operating procedures and US FDA regulations. Responsible of performing all PV reporting activities appropriately including; tracking, coding (MedDRA) and computer entry in order to accomplish the established targets of compliance, quality and productivity.

Community pharmacist

Research program at Utrecht University, Biopharmacy and Pharmaceutical Technology Department of Pharmaceutics.