PV/RA Specialist

Date:  28-Jan-2023
Department:  Medical/QA/Regulatory Affairs/Pharmacovigilance
Team:  R&D, Pharmacovigilance & Regulatory Affairs
Job Type:  Direct Employee
Contract Type:  Permanent
Location: 

Amsterdam, NL

Purpose

 

The Pharmacovigilance & Regulatory Affairs Specialist Benelux, in close cooperation with Chiesi HQ in Italy, is responsible for obtaining new registrations of medicines and maintaining existing registrations. In addition, he/she ensures compliance with the local regulatory requirements for the commercialization of medicines. He/she also ensures the coordination and execution of all tasks required in the context of pharmacovigilance in accordance with the applicable legal requirements and the quality standard of both Chiesi HQ and Chiesi Benelux.  There is also an important focus on the maintenance, implementation and continuous improvement of the quality management system for Regulatory Affairs and Pharmacovigilance.

Main Responsibilities

 

Pharmacovigilance

 

The safety of Chiesi's medicines is systematically and continuously checked and monitored, in such a way that possible harmful consequences of the use of the medicines are prevented and inspections can take place at all times and run optimally. 

 

To achieve this result, some of the activities are described below.

  • Supporting the implementation, maintenance and continuous improvement of the Pharmacovigilance Quality System at the local level in accordance with the applicable legal requirements and the quality standard of Chiesi Global and Chiesi Benelux;
  • Ensures awareness of incoming safety and/or pharmacovigilance data;
  • Records, documents, reports and follows up on incoming security alerts
  • Monitors the compliance of Chiesi Benelux and creates awareness within the organization for reporting side effects and the procedures to be followed, among other things by drawing up and managing training plans (internal & external);
  • Drafts and manages PV agreements in accordance with Chiesi HQ procedures;
  • Oversees service providers in terms of delegated activities to verify the adequacy of existing processes and to ensure compliance with the requirements set out in the agreement;

 

Regulatory Affairs 

 

Ensures Chiesi medicines meet all requirements for effectiveness and safety, so that the health authority(ies) approve new medicines and registrations of existing medicines are maintained and medicines become and remain available to patients.

 

To achieve this result, some of the activities are described below.

  • Supports in the implementation, maintenance and continuous improvement of the Regulatory Quality System at the local level in accordance with the applicable legal requirements and the quality standard of Chiesi HQ and Chiesi Benelux;
  • Ensures that all current and future Chiesi products meet the legal requirements in Belgium, the Netherlands and Luxembourg;
  • Prepares, in collaboration with Chiesi HQ, the submission and adjustment of registration dossiers, provided with a scientific substantiation;
  • Maintains local product information in close cooperation with Chiesi HQ: Summary of Product Characteristics (SmPC), patient information leaflet and packaging material;
  • Contributes in collaboration with Chiesi HQ to the development and control of packaging material and monitors the timelines for implementation of the correct packaging material in accordance with the quality requirements set by Chiesi and legislation and in coordination with MEB and EMA;
  • Ensures that the Chiesi Benelux organization is aware of changes to local SmPCs and packaging materials;
  • Ensures to be up-to-date with the latest legislation and developments of the regulatory authorities and also monitors the compliance of Chiesi Benelux.

Experience Required

 

  • Bachelor's degree working and thinking level, preferably a bachelor's degree in a biomedical or biopharmaceutical direction.
  • Excellent oral and written communication skills in both Dutch and English;
  • Knowledge of and experience within the pharmaceutical care field;
  • Knowledge of medical terminology;
  • At least 2 years of work experience in the field of pharmacovigilance or regulatory affairs;
  • Experience with the use of digital information systems;
  • Experience with project management and independently managing and coordinating projects.

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