Medical Safety Writer

Company Mission :

• We want to be recognized as an international group focused on research, able to develop and commercialize innovative therapeutic solutions to improve the quality of people's lives.
• We intend to maintain a high quality entrepreneurial team, characterized by a spirit of cooperation and self-confidence.
• Our goal is to combine commitment to results with integrity while operating responsibly from both a social and environmental point of view.

Job 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

S ummary of Key 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
• Prepare, maintain 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).

• Prepare, maintain 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) / 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

Required Skills :

• Bachelor or Master degree in medicine, PhD or similar in the field of Biosciences preferred
• Minimum 5 years of experience in international pharmacovigilance within Pharmaceutical and / or Biotechnology industry, with at least 3 years of experience in medical safety writing
• Excellent communication, interpersonal and leadership skills
• Strategic thinking, effective judgement, problem solving and decision making skills
• Planning, organizational and analytical skills, with a detail- and result-oriented approach
• Proven ability in managing performance and projects, thanks to a deep expertise in medical safety writing activities (e.

g. preparation of aggregate reports)

• Ability to organize and prioritize tasks both individually and across team to achieve established deadlines while maintaining high-quality performances
• Deep and up-to-date knowledge of local / international reporting and regulatory regulations to ensure compliance
• Knowledge of safety database and other concerned data management systems.

Supervisory Responsibility :

Direct Reports : No

Indirect Reports : None

Confidential Data : Yes