Pre-Market Pharmacovigilance Specialist
7 giorni fa
**Department**: Global Pharmacovigilance
**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, 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
Participate to the Departmental meetings and cross-functional teams/study Specific teams
Compile and review of documents pertinent to clinical trials with regards to PV topics/involvement (e.g.
study protocols, patient information sheets, request for proposal, clinical study reports, AE coding listings), including set-up of electronic SAE (eSAE) reporting and PV sections of investigator's brochures (IBs)
Set up of systems/tools suitable for PV management within a specific clinical trial (e.g.
study configuration in the safety database, (e)SAE form creation, web portals, etc)
Attendance and presentation at investigators meetings, if applicable and review of investigators training materials
Monitor PV operations activities of CROs involved in clinical trials
Evaluate product quality complaints from clinical trials
Draft and update PV Agreements with monitoring CRO
Manage of clinical trials and Compassionate use/expanded access programs (where applicable)
Maintain compliance to relevant regulations, policies and procedures
Fill in registers used for cases compliance analysis and PSMF update
Support the line manager in developing and maintaining global SOPs/ WIs concerning clinical trials, according to the assigned task
Implement PV training programs in connection with the assigned tasks
Perform SAE/Adverse events of Special Interest (AESIs) reconciliation activities
Directly handle/oversight Individual Case Safety Reports (ICSRs)/pregnancy cases from clinical trials from receipt to submission (interaction with monitoring Contract Research Organizations - CROs)
Support the Global Pharmacovigilance Operations Third Parties Specialist and the Case medical review physician for activities performed by Pharmacovigilance Service Providers (PVSPs)
Prepare PV documents for their management and archiving in the (e)TMF
Upload PV documents in the EDMS through the appropriate workflows
Monitor the EMA and other international websites or tools for the activities under direct responsibility and to distribute the relevant information to concerned stakeholders
Monitor specific tools for PV intelligence purposes
Handle ICSRs related to clinical trials as contingency plan
Open deviations related to the activities under the role and contribute to the investigation(s) and CAPA Plan implementation
Operate as backup according to Head of Pre-Market unit's indications
Participate in audit and inspection activities
Experience Required
Minimum 1-3 years of experience in Pharmacovigilance within Pharmaceutical and/or Biotechnology industry
Experience in clinical trials safety preferred
Education
Master degree in science, medicine, biology, pharmacy or related fields
Additional specific courses in Pharmacovigilance are considered a plus
Languages
Fluent English
Technical Skills
Good communication and interpersonal skills, with ability to
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