Jr Drug Safety Unit Specialist
Role overview
Description The resource will be inserted within the Drug Safety Unit (DSU) and will support pharmacovigilance activities related to IBSA products both in post-marketing and clinical development phases.
## Tasks - Management of pharmacovigilance cases deriving from post-marketing experience, including: - Collection, recording and management of adverse events/adverse reactions (AE/ADR) from UE and extra-UE, from any source - Download and management of Individual Case Safety Reports (ICSR) from EMA (EVWEB and MLM) and from other national databases - Notification to Competent Authorities (EMA and local NCA), where applicable - Follow-up activities on cases - Reconciliation activities with Business Partners, Service Providers and IBSA departments - Preparation of Periodic Benefit-Risk Evaluation Reports (PBRER) and ACOs for IBSA products - Support to the management of pharmacovigilance activities in the context of clinical development, including: - Review of clinical study documentation - Continuous monitoring of safety - Management of Serious Adverse Events (SAE) from clinical trials - Preparation and submission of Development Safety Update Report (DSUR) for IBSA investigational medicinal products - Drafting, updating and maintenance of SOPs and Working Instructions related to pharmacovigilance activities - Preparation and management of Pharmacovigilance Agreements (PVA) for the exchange of safety information within the IBSA Group and with third parties - Provision of pharmacovigilance training to the DSU and other IBSA Group departments ## Requirements - Degree in scientific disciplines (e.g.
CTF, Pharmacy, Biology, Biotechnology or similar) - At least 2 years of experience in Pharmacovigilance - Good knowledge of English, written and spoken - Knowledge of ICH, EMA, UK, Swissmedic legislation and guidelines applicable to Pharmacovigilance - Mastery of computer tools ## What we offer - Not specified ## Contact - Not specified
Description
Description The resource will be inserted within the Drug Safety Unit (DSU) and will support pharmacovigilance activities related to IBSA products both in post-marketing and clinical development phases.
## Tasks - Management of pharmacovigilance cases deriving from post-marketing experience, including: - Collection, recording and management of adverse events/adverse reactions (AE/ADR) from UE and extra-UE, from any source - Download and management of Individual Case Safety Reports (ICSR) from EMA (EVWEB and MLM) and from other national databases - Notification to Competent Authorities (EMA and local NCA), where applicable - Follow-up activities on cases - Reconciliation activities with Business Partners, Service Providers and IBSA departments - Preparation of Periodic Benefit-Risk Evaluation Reports (PBRER) and ACOs for IBSA products - Support to the management of pharmacovigilance activities in the context of clinical development, including: - Review of clinical study documentation - Continuous monitoring of safety - Management of Serious Adverse Events (SAE) from clinical trials - Preparation and submission of Development Safety Update Report (DSUR) for IBSA investigational medicinal products - Drafting, updating and maintenance of SOPs and Working Instructions related to pharmacovigilance activities - Preparation and management of Pharmacovigilance Agreements (PVA) for the exchange of safety information within the IBSA Group and with third parties - Provision of pharmacovigilance training to the DSU and other IBSA Group departments ## Requirements - Degree in scientific disciplines (e.g.
CTF, Pharmacy, Biology, Biotechnology or similar) - At least 2 years of experience in Pharmacovigilance - Good knowledge of English, written and spoken - Knowledge of ICH, EMA, UK, Swissmedic legislation and guidelines applicable to Pharmacovigilance - Mastery of computer tools ## What we offer - Not specified ## Contact - Not specified