Pharmacovigilance Specialist
Parma, IT
About us
Based 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 researches, develops and markets innovative drugs in its main therapeutic areas: Discover more here
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.
We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.
In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.
Chiesi Research & Development
Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, chemical manufacturing and controls, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. 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 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 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
Experience Required
3 years of experience in Pharmacovigilance within Pharmaceutical and/or Biotechnology industry, with at least 1 years of experience in Post-Market safety
Education
- Master degree in science, medicine, biology, pharmacy or related fields;
- Additional background in Pharmacovigliance will be considered as a plus
Languages
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 (e.g. Good Pharmacovigilance Practices)
- IT Skills: Office package; safety database and other data management systems
Soft Skills
- 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.
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