Pharmacovigilance Specialist
1 settimana fa
Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden) and Toronto (Canada).Who we are looking forMain Responsibilitieswill be responsible for conducting comprehensive reviews of adverse event reports for investigational and post-marketed products, ensuring compliance with regulatory guidelines and completeness of documentation.Assist in developing Safety forms, standard operating procedures, and process guidelines,Assist in signal detection activities and provide line listings for review,Collaborate with cross-functional teams e.g. Clinical Operations, Medical Affairs,Provide advice to Affiliates in managing local Non-interventional studies and other organized data collection PV activitiesCompile, review and archive documents pertinent to non-interventional studies with regards to PV topics/involvement (e.g. study protocols, request for proposal, clinical study reports, AE/ADR coding listings), including set-up of both electronic ADR reporting and systems/tools suitable for PV management within a specific NIS or other Organized Data Collection Systems (ODCS)Support negotiation of agreements and manage PV operations activities of Contract Research Organizations (CROs)/ other service providersOversight of all product complaints and medical enquiries for the specific product portfolioDevelop and maintain Global SOPs/ WIs concerning for GPV OperationsGuarantee the PV management in Company sponsored controlled websites/Apps and other social media at corporate and local levelOversight Individual Case Safety Reports (ICSRs) from non-interventional studies and ODCS from receipt to submission (interaction with monitoring Contract Research Organizations - CROs)Perform cases reconciliation activities with external (e.g. AE/AESI/ADR with CRO, service providers) and internal stakeholders (e.g. ADRs with Medical, Legal, Manufacturing)Be member of the literature monitoring team contribute to the maintenance of the Company Pharmacovigilance System Master File Handle Open deviations related to the activities under the role and contribute to the investigation(s) and CAPA Plan implementationExperience Required3 years of experience in Pharmacovigilance within Pharmaceutical and/or Biotechnology industry, with at least 1 years of experience in Post-Market safetyEducationMaster degree in science, medicine, biology, pharmacy or related fields;Additional background in Pharmacovigliance will be considered as a plusLanguagesFluent englishTechnical SkillsKnowledge of national and international regulatory safety reporting requirementsKnowledge of MedDRA coding dictionary and its principles Ability in managing performance and projectsUp-to-date knowledge of local/ global post-market regulations (e.g. Good Pharmacovigilance Practices)IT Skills: Office package; safety database and other data management systemsSoft SkillsGoal orientation Team working Quality orientation Attention to details Customer orientation What we offerYou would join a dynamic, fast-growing, challenging and friendly environment. In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.
-
Pharmacovigilance Specialist
Trovato in: Whatjobs IT C2 - 5 giorni fa
Parma, Italia Chiesi Group A tempo pienoWho we are looking for Main Responsibilities will be responsible for conducting comprehensive reviews of adverse event reports for investigational and post-marketed products, ensuring compliance with regulatory guidelines and completeness of documentation. Assist in developing Safety forms, standard operating procedures, and...
-
Pharmacovigilance Specialist
Trovato in: Talent IT C2 - 2 settimane fa
Parma, Italia Chiesi Group A tempo pienoWho we are looking for Main Responsibilities will be responsible for conducting comprehensive reviews of adverse event reports for investigational and post-marketed products, ensuring compliance with regulatory guidelines and completeness of documentation. Assist in developing Safety forms, standard operating procedures, and process...
-
Device Specialist
3 giorni fa
Parma, Italia Chiesi Farmaceutici A tempo pienoDevice Specialist - Maternity Leave Date: Feb 6, 2023 Department: GTD Global Technical Development **Job Type**: Direct Employee Team: R&D, Pharmacovigilance & Regulatory Affairs Contract Type: Temporary **Location**: Parma, IT Main Responsibilities Experience Required one or few years of professional experience in the HFE and ideally in the development...
-
Regulatory Affairs Specialist
7 giorni fa
Parma, Italia Chiesi Farmaceutici A tempo pieno**Data**: 30-mar-2023 **Dipartimento**: Global Regulatory Affairs **Team**: R&D, Pharmacovigilance & Regulatory Affairs **Tipo Lavoro**: Dipendente **Tipologia Contratto**: Tempo indeterminato **Località**: Parma, IT About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’...
-
Gra Eu Regulatory Affairs Junior Specialist
7 giorni fa
Parma, Italia Chiesi Farmaceutici A tempo pieno**Date**: 30-Mar-2023 **Department**: Global Regulatory Affairs **Team**: R&D, Pharmacovigilance & Regulatory Affairs **Job Type**: Direct Employee **Contract Type**: Permanent **Location**: Parma, IT About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience,...
-
Global Ra Junior Specialist Extra Eu
3 giorni fa
Parma, Italia Chiesi Farmaceutici A tempo pieno**Date**: Jun 26, 2023 **Department**: Global Regulatory Affairs **Job Type**: Direct Employee **Team**: R&D, Pharmacovigilance & Regulatory Affairs **Contract Type**: Permanent **Location**: Parma, IT About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience,...
-
Clinical Compliance Specialist
7 giorni fa
Parma, Italia Chiesi Farmaceutici A tempo pieno**Date**: 30-Mar-2023 **Department**: Global Clinical Development **Team**: R&D, Pharmacovigilance & Regulatory Affairs **Job Type**: Direct Employee **Contract Type**: Temporary **Location**: Parma, IT About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience,...
-
GCP Compliance Specialist
6 giorni fa
Parma, Italia Chiesi A tempo pienoAbout usBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group...