KCR is a clinical development solutions provider for the biotechnology and pharmaceutical industries. We support clients with full:service clinical development capabilities across three main areas:Trial Execution, Consulting and Placement. KCR now operates across five regions:North America, Western Europe, Central Europe, Eastern Europe, and Australia, with a main operational hub located in Boston, MA. Our strategic hub locations, technical capabilities and solution offerings allow for the optimized delivery of trial execution strategies to develop life:changing therapies. KCR offers access to an estimated population of 1.1 Billion people. kcrcro.KCR is a clinical development solutions provider for the biotechnology and pharmaceutical industries. We support clients with full:service clinical development capabilities across three main areas:Trial Execution, Consulting and Placement. KCR now operates across five regions:North America, Western Europe, Central Europe, Eastern Europe, and Australia, with a main operational hub located in Boston, MA. Our strategic hub locations, technical capabilities and solution offerings allow for the optimized delivery of trial execution strategies to develop life:changing therapies. KCR offers access to an estimated population of 1.1 Billion people. kcrcro.WE SEE HUMAN BEHIND EVERY NUMBERSenior Pharmacovigilance Specialist**Location**:Poland (home:/ office:based)Senior Pharmacovigilance Specialist is responsible for realization of safety management/Pharmacovigilance (PV) activities mainly related with different aspects of adverse event information processing according to Standard Operating Procedures (SOP), project specific plans, ICH Good Clinical Practice (ICH GCP), Good Pharmacovigilance Practice (GVP)and all other applicable regulations and standards. Senior Pharmacovigilance Specialists tasks depend on the process/project/role assigned.The duties associated with the role include:Receives and processes adverse event (AE) reports and other information related with adverse events of medicinal products and medical devices according to applicable regulatory requirements, SOPs, Safety Management Plans and guidelines;Performs review, analysis, triage and filing of AE information within established timeframes;Processes AE information in relevant computerized system (e.g. PV database):data entry, encoding, case narrative writing, quality control, reconciliation;Ensures quality, compliance and consistency of all steps of AE processing activities (case management);Cooperates with Medical Monitor/Medical Reviewer and Investigators to collect all required information and determine AE medical assessment;Coordinates workload arrangement activities to ensure timely and adequate distribution of workload for assigned team;Receives, verifies and/or assists in preparation (writing, compilation) of expedited and periodic safety reports (including Suspected Unexpected Serious Adverse Reactions (SUSAR), DSUR, Line listings, IND safety reports);Performs safety reports submissions to investigators, regulatory authorities (RA) (including EudraVigilance) and ethics committees (EC) within established timeframes and according to relevant regulatory requirements and SOPs;Communicates with RA, EC and investigational sites to ensure safety reports are delivered and acknowledgement of receipt is collected;Assists in collection,verification and tracking of local and global safety reporting requirements;Develops PV documentation including:SOPs, instructions, Safety Management Plans under PV Manager supervision;Ensures that all PV documents are filed according SOPs and project requirements;Effectively communicates with internal and external stakeholders, participates in internal and external team meetings;Develops PV knowledge by participating in internal/external trainings and by self:learning.**Requirements**:Bachelors degree, Masters degree or certi
