About us
At Chiesi, we are an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with more than 7,000 employees.
We are committed to improving people's quality of life by acting responsibly towards society and the environment.
We are a global family made up of different cultures, genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.
Chiesi Research & Development
The R&D team is a fundamental asset for our business.
Our pipeline projects include discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management.
Headquartered in our 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, Toronto, Canada and Shanghai, China.
Main Responsibilities
You will be responsible for conducting comprehensive reviews of adverse event reports for investigational and post-marketed products.
This includes ensuring compliance with regulatory guidelines and completeness of documentation.
You will assist in developing Safety forms, standard operating procedures, and process guidelines.
You will collaborate with cross-functional teams such as Clinical Operations, Medical Affairs.
You will provide advice to Affiliates in managing local Non-interventional studies and other organized data collection PV activities.
You will compile, review and archive documents pertinent to non-interventional studies with regards to PV topics/involvement.
You will oversee all product complaints and medical enquiries for the specific product portfolio.
You will develop and maintain Global SOPs/WIs concerning GPV Operations.
You will guarantee the PV management in Company sponsored controlled websites/Apps and other social media at corporate and local level.
You will oversee Individual Case Safety Reports (ICSRs) from non-interventional studies and ODCS from receipt to submission.
You will perform cases reconciliation activities with external and internal stakeholders.
You will contribute to the maintenance of the Company Pharmacovigilance System Master File.
You will handle open deviations related to the activities under the role and contribute to the investigation(s) and CAPA Plan implementation.
Experience Required
3 years of experience in Pharmacovigilance within Pharmaceutical and/or Biotechnology industry.
At least 1 year of experience in Post-Market safety.
Education
Master degree in science, medicine, biology, pharmacy or related fields.
Additional background in Pharmacovigilance will be considered as a plus.
Language
Fluent English.
Technical Skills
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.
IT skills: Office package; safety database and other data management systems.
Soft Skills
Goal orientation.
Quality orientation.
Team working.
Attention to details.