Pharmacovigilance Specialist

• 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 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 activities
• Compile, 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 providers
• Oversight of all product complaints and medical enquiries for the specific product portfolio
• Develop and maintain Global SOPs/ WIs concerning for GPV Operations
• Guarantee the PV management in Company sponsored controlled websites/Apps and other social media at corporate and local level
• Oversight 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 implementation

3 years of experience in Pharmacovigilance within Pharmaceutical and/or Biotechnology industry, with at least 1 years of experience in Post-Market safety
 

• Master degree in science, medicine, biology, pharmacy or related fields;
• Additional background in Pharmacovigliance will be considered as a plus
   

Fluent english

• Knowledge of national and international regulatory safety reporting requirements
• Knowledge of MedDRA coding dictionary and its principles Ability in managing performance and projects
• Up-to-date knowledge of local/ global post-market regulations (e.g. Good Pharmacovigilance Practices)
• IT Skills: Office package; safety database and other data management systems
   

• Goal orientation
• Team working
• Quality orientation
• Attention to details
• Customer orientation

What we offer

You 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.