Anna Bąk Email & Phone Number

Warsaw, Pl

- Audit strategy, annual audit programme preparation and maintaining- Conducting internal, external and qualification audits- Approving CAPAs and follow-up of their fulfilment - Risk assessment of partners and internal processes- Improving internal quality system- Creation and update of internal quality documents

- Compliance monitoring in terms of ICSRs – timelines, compliance with internal SOPs and international guidelines

- Management of Individual Case Safety Reports (assessment, coding with MedDRA, validation, entrance to database)- Routine signal management process- Medical data review- Review of European and Polish website of competent authorities with tracking of changes in terms of pharmacovigilance- Periodic Safety Update Reports preparation and submission (within EU and out of EU)- Addendum to the Clinical Overview preparation (within EU and out of EU)- Pharmacovigilance System… Show more - Management of Individual Case Safety Reports (assessment, coding with MedDRA, validation, entrance to database)- Routine signal management process- Medical data review- Review of European and Polish website of competent authorities with tracking of changes in terms of pharmacovigilance- Periodic Safety Update Reports preparation and submission (within EU and out of EU)- Addendum to the Clinical Overview preparation (within EU and out of EU)- Pharmacovigilance System Master File update- Preparation and update of Instructions and Standard Operation Procedures concerning pharmacovigilance- Preparation, performing and participation in audits in scope of Pharmacovigilance- Preparation and performing pharmacovigilance training- Risk Management Plan preparing and updating- Knowledge regarding law and regulations concerning Pharmacovigilance in EU and out of EU- Submission and update of medical products data within xEVMPD- Preparing and updating Pharmacovigilance Safety Data Exchange Agreement- Cooperation with international Partners in terms of reconciliation of safety data Show less

Master Of Phar, Pharmacy

Activities and Societies: Students Scientific Society Pharmaceutical Care Panaceum Students Scientific Society Pharmacoeconomic

Education record

Erasumus programme Pharmacoeconomic department Projects: Drugs reimbursement system in Poland Differences in reimbursement and pricing.