Medical Safety Writer

**Date**: 21-Feb-2023
**Department**: Global Pharmacovigilance
**Team**: R&D, Pharmacovigilance & Regulatory Affairs

**Job Type**: Direct Employee
**Contract Type**: Permanent

**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

Purpose

Assisting the Head of Risk Management Unit in the maintenance of products’ registration worldwide and in supporting the clinical development, by means of planning, managing and drafting aggregate reports’ and related activities

Main Responsibilities
- Planning of PSURs and DSURs related to corporate products and oversight of the PSUR planning for non-corporate (local) products.
- Track the EU PSURs submissions into the Regulatory Data management system
- Maintain, prepare and submit Periodic Safety Update Reports (PSURs)/ Periodic Benefit-Risk Reports (PBRERs) and other reports or documents related to requests from Health Authorities (e.g. Requests for Supplementary Information
- RSI).
- Maintain, prepare and submit Development Safety Update reports (DSURs)
- Collaborate with Regulatory Affairs for the planning and submission of any aggregate reports and archive/store the documentation
- Write the relevant sections of documents necessary for Company products' renewals and provide support in case of RSI during the renewal procedure
- Assist the Risk management physician in preparing safety communications (e.g. DHPC package)
- Participate to the creation and update of Company Core Safety Information (CCSI) and Company Core Data Sheet (CCDS) for corporate products (where applicable) in line with Chiesi policies and procedures
- Monitor that data used for aggregates are up-to-date (both at Corporate and Affiliates level) and Cooperate with GPV Office for regulatory compliance analysis and report generation
- Liaise with functions outside of pharmacovigilance area to ensure full understanding of the aggregate reports and their role
- Open deviations related to the activities under the role and contribute to the investigation(s) and CAPA Plan implementation
- Review new regulations and ensure implementation into current workflow and administer appropriate training when necessary.
- Monitor FDA, EMA, HMA and EC websites with reference to PSUSA assessment and communication to concerned stakeholders
- Develop and maintain Global SOPs/ WIs in the field and administer training
- Participate in audit and inspection activities

Experience Required

Minimum 5-7 years of experience in international pharmacovigilance within Pharmaceutical and/or Biotechnology industry, with at least 3-5 years of experience in medical safety writing

Education

PhD or similar in the field of Biosciences preferred

Languages

English fluent

Soft Skills
Communication skills
Leadership and social influence
Planning and organizational skills
Problem solving

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