Based in a Global Drug Safety Unit (GDSU) in Vilnius, Pharmacovigilance Specialist together with a Head of GDSU and other associates sets up and maintains an efficient pharmacovigilance system in compliance with the national and European Union (EU) regulations for medicinal products, food supplements and medical devices.

 

 ·        Ensures collection, processing, following up, assessment and archiving of all Adverse Drug Reactions (ADR) reports from all sources involving external service providers as appropriate;

·        Ensures timely entering the data of ADR/event reports to the European Medicines Agency (EMA) to EudraVigilance, U.S. Food and Drug Administration (FDA) and any other Health Authorities systems and companys database;

·        Ensures permanent monitoring of EudraVigilance system with regards to the safety data of medicinal products of the represented Marketing Authorisation Holders (MAHs);

·        Supports preparation of Periodical Safety Update Reports (PSUR) and Periodical Adverse Drug Experience Report (PADER);

·        Ensures timely submission of PSURs/PADERs to the central EU/US repository and, if required, to local Health Authorities;

·        Ensures preparation of Risk Management Plans (RMP), as applicable;

·        Ensures establishment, review, update and termination of the Safety Data Exchange Agreements (SDEA) and/or Pharmacovigilance Agreements, as applicable with the business partners of the MAHs;

·        Screens ADR reports of the medicinal products for represented MAHs in the global scientific literature;

·        Monitors Health Authorities websites for possible safety referrals and signals regarding the products of represented MAHs;

·        Monitors all pharmacovigilance related regulations and informs immediately about all important changes;

·        Supports preparation for possible pharmacovigilance inspections by Health Authorities and audits by represented MAHs or internally;

·        Supports the implementation of corporate and local SOPs and WIs for pharmacovigilance related activities;

·        Supports deviations management, that relates to pharmacovigilance activities;

·        Supports the implementation of the additional safety measures (i.e. Direct Health Care Professional letters, etc.);

·        Ensures safety signal detection and management for the medicinal products;

·        Supports preparation of adequate pharmacovigilance training for local personnel and, if needed, the Contract Research Organization (CRO) staff;

·        Performs comparison of the Companys products safety information versus the reference product, issues the Company Core Data Sheet (CCDS) and timely informs relevant Regulatory Affairs functions about the need of implementation via the safety variations;

·        Ensures timely update of the product information data in EU Article 57 data base (XEVMPD) for the Company products;

·        Supports other company departments in all drug safety related issues.