SAEs/SUSAR/ADR assessment and management in AERs database, narratives, regulatory reporting coordination. IB updates, writing DSUR/PSUR, RMP. Eudravigilance validations (GATEWAY). Safety reconciliations with data management (clinical trials). Literature search for ADR, safety reconciliation with medical information.

Mainly involved in Clinical Trials: management of SAEs, SUSARs, ARGUS safety database maintenance. Responsible person for Eudravigilance for clinical trials involving several countries. Coordination of SUSAR submission through Eudravigilance and/or each countries own database as applicable (e.g ToetsingOnline in the Netherlands). Validations with Eudravigilance, testing with EMA and other countries. Writing DSUR/ASR, managing/coordinating submissions. Performing reconciliations with data management.

-Coordination of international pharmacovigilance activities.-Planning and performing audits to international partners (East Europe).-Internal and external staff training. -Quality Coordinator for Pharmacovigilance (pharmacovigilance system, SOPs, detection and implementation of corrective actions)-Signal detection and risk management activities-Prepare Periodic Safety Update Reports (PSURs) and regulatory dossiers.-Prepare Annual Safety Reports (ASR/DSUR)-Responding as necessary to Medical Information safety queries-Implementation, administration and management of the global pharmacovigilance database ARISg.-Case processing (all steps)

-Processing ADR reports from spontaneous reporting and submission (if required) the Spanish medicine Agency via FEDRA.-Submission and review of periodic safety update reports-Literature reviews-Responding (as necessary) to Medical Information safety queries-Internal and external staff training. -Manage the operational activities related to the planning, implementation, and reporting of phase II and III clinical trials.-Identifying, resolving, escalating issues, and communicating study status and deliverables.

-Designing data collection forms, known as case record forms (CRFs).-Managing regulatory authority applications and approvals.-Liaising with doctors/consultants (or investigators) on conducting the trial -Setting up the study centers, which includes ensuring each centre has the trial materials and training site staff to trial-specific industry standards -Monitoring the trial throughout its duration, this involves visiting the study centers on a regular basis.-Verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV). -Closing down study centers on completion of the trial.-Preparing final reports and occasionally manuscripts for publication.

-Management of biomedical databases.-Literature searches.-Support for patients and professionals (Tel, fax, email)