Jr Drug Safety Unit Specialist
Role overview
Job Description The resource will be inserted within the Drug Safety Unit (DSU) and will support the pharmacovigilance activities related to IBSA products both in the post-marketing phase and in the clinical development phase.
## Responsibilities - Management of pharmacovigilance cases derived from post-marketing experience, including: - Collection, registration, and management of adverse events/reactions (AE/ADR) from the EU and extra-EU, 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 Partner, Service Provider, and IBSA departments - Preparation of Periodic Benefit-Risk Evaluation Reports (PBRER) and ACO for IBSA products - Support to the management of pharmacovigilance activities in the clinical development phase, including: - Review of clinical study documentation - Continuous monitoring of safety - Management of Serious Adverse Events (SAE) from clinical studies - Preparation and submission of the Development Safety Update Report (DSUR) for IBSA experimental medicines - Redaction, update, and maintenance of SOP 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 departments of the IBSA Group ## Requirements - Bachelor's degree in scientific disciplines (e.g.
CTF, Pharmacy, Biology, Biotechnology, or related) - At least 2 years of experience in Pharmacovigilance - Good knowledge of the English language, written and spoken - Knowledge of applicable ICH, EMA, UK, Swissmedic legislation and guidelines - Proficiency in computer tools ## What We Offer - Opportunity to work within a dynamic and professional team - Stimulating and innovative work environment - Opportunity for professional growth and personal development ## Contact - Contact us for further information on the position and the selection process.
Description
Job Description The resource will be inserted within the Drug Safety Unit (DSU) and will support the pharmacovigilance activities related to IBSA products both in the post-marketing phase and in the clinical development phase.
## Responsibilities - Management of pharmacovigilance cases derived from post-marketing experience, including: - Collection, registration, and management of adverse events/reactions (AE/ADR) from the EU and extra-EU, 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 Partner, Service Provider, and IBSA departments - Preparation of Periodic Benefit-Risk Evaluation Reports (PBRER) and ACO for IBSA products - Support to the management of pharmacovigilance activities in the clinical development phase, including: - Review of clinical study documentation - Continuous monitoring of safety - Management of Serious Adverse Events (SAE) from clinical studies - Preparation and submission of the Development Safety Update Report (DSUR) for IBSA experimental medicines - Redaction, update, and maintenance of SOP 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 departments of the IBSA Group ## Requirements - Bachelor's degree in scientific disciplines (e.g.
CTF, Pharmacy, Biology, Biotechnology, or related) - At least 2 years of experience in Pharmacovigilance - Good knowledge of the English language, written and spoken - Knowledge of applicable ICH, EMA, UK, Swissmedic legislation and guidelines - Proficiency in computer tools ## What We Offer - Opportunity to work within a dynamic and professional team - Stimulating and innovative work environment - Opportunity for professional growth and personal development ## Contact - Contact us for further information on the position and the selection process.