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 31 countries with more than 7,000 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.
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, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management.
Who we are looking for
Purpose
Process owner (cross-functional) for developing a wide range of pharmacovigilance documents for the assigned global products within the specific therapeutic area, including but not limited to Periodic Safety Reports, Safety Strategy and Core Benefit-Risk Documents.
Main Responsibilities
- Aggregates (PBRERs, PADERs, DSURs, ACOs)
- To support the Coordinator in the global planning (for both molecules under development and those with a Marketing Authorisation);
- To be responsible for writing, consolidating, updating and distributing aggregates for global products with the cross-functional team;
- To be responsible for aggregates report submission to Health Authorities where applicable;
- To be responsible for compliance monitoring both for PSURs/PBRERs and DSURs submitted for global products/ molecules under development;
- To be QC Responsible for aggregate reports and global planning;
- To lead the process/project for cross-functional working teams;
- To manage related Health Authorities’ assessments (i.e., “requests for supplementary information -RSI);
- To support the Safety Physicians in writing the relevant sections of the documents for the Company products’ renewals in Addendum to the clinical overviews (ACOs) for global products and provide the necessary support in case of RSI during the renewal procedure;
- To support/act as QC responsible the Coordinator in the calculation of quality Aggregate KPIs;
Risk Management Materials
- To support TA Physicians in aligning risk management materials with the current approved documents including PBRER, ACO, PADER, RMP, presentations, and signal evaluations;
General
- To produce high-quality, accurate and fit-for-purpose documents with clear conclusions;
- To effectively and clearly communicate technical, medical, and scientific information in critical submission and internal PV documents to deliver high-quality reports within the specified timelines;
- To collaborate cross-functionally for continuous improvement of standards and best practices for medical writing;
- To upload pharmacovigilance documents for global products in the EDMS through the appropriate workflows;
- To monitor aggregates inbox and HA websites including CTIS for aggregate management purposes (e.g. EURD list, ASR RFI) and share the results with relevant stakeholders;
- To be the representative for MSW part in audits and inspections;
- To support QPO in compliance calculations related to PSURs/PBRERs and DSURs submission and to update the Regulatory Information Management System with PSURs/PBRERs submission in scope;
- To support QPO for SOPs and other controlled documents including Working Instruction and related training;
- To support QPO for service agreement preparation concerning aggregates.
Experience Required
Minimum 1 year of experience in pharmacovigilance (medical writing experience is preferred), with theoretical and/or practical knowledge of PSUR/PBRER, ACO, RMP and DSURs.
Education
Master’s degree in science, PhD or similar preferred
Languages
Technical Skills
Capacity to work on situations or data requiring an in-depth evaluation of various factors:
- Data analysis;
- Previous medical writing experience;
- Procedures writing and training performance;
- Knowledge of domestic and international regulatory safety reporting requirements
Soft Skills
- Adaptability and flexibility
- Conflict management
- Quality 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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