République tchèque 10.09.2021

Senior (Advanced) Safety Officer

Tasks

AIXIAL is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV), non-interventional studies and post-marketing activities. Our offices are located in France, Denmark, Switzerland, Belgium, Germany and the Czech Republic.

We are currently looking for a Senior (Advanced) Safety Officer, who will ensure the good performance of post-marketing pharmacovigilance project, which is entrusted to him, in accordance with the specifications contracted with customers, in compliance with regulations, ethics, quality and compliance with procedures and deadlines.This includes, but is not limited to:

Main Responsibilities:

  • Manage a project as Project Manager, provides a priority interface with the client, supports the development of SDEAs, tools and documents for this project and their implementations, supports Billing and Financial Status development, establishes Workplans, participates in Client Meetings and proposes, if needed, any improvement solution
  • Management of Adverse Events for assigned project, in accordance with applicable regulations and procedures
  • Global and Local literature survey concerning the entrusted products and the corresponding pathologies
  • Participation in monitoring of regulation for Vigilance activities (pre- and post-marketing);
  • Preparation of Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), Addendum of Clinical Overview (ACO), Signal detection
  • Participate in preparation and attendance of audits and inspections, as well as in the implementation of corrective or preventive action of CAPAs
  • Theoretical knowledge and practical skills in MedDRA and WHO DD coding
  • Participation in definition of human resources needs for the projects on which he is assigned in consultation with the Head of the departmen

Requirements

Senior Safety Officers should have:

  • A university degree in Pharmacy, health science, medicine or a related discipline
  • 4 to 6 years of relevant experience in pharmacovigilance;
  • Experience of work in multinational company
  • Good knowledge of the regulations (GVP, ICH, GCP) and tools related to the activity (databases, Eudravigilance)

We are seeking candidates who possess, among other skills, the following:

  • Autonomy and a sense of responsibility
  • Analytical and synthesis skills
  • Ability to use simple language based on target audience
  • Project team coordination
  • Ability to keep tight deadlines and work under pressure
  • Ability to inspire confidence and mutual respect
  • Excellent communication skills with different internal and external stakeholders
  • Fluency in English (French as advantage)
  • Scientific expertise
  • Versatility
  • Meticulousness and attention to detail
  • Planning skills and organized work habits

We provide:

  • An opportunity to work in international team
  • An attractive finance bonuses according to a good result
  • Young and friendly team
  • 25 days of holiday per year (instead of the standard 20 as per Czech law)
  • Pleasant offices in the center of Brno or Prague
  • A possibility of professional courses and international conferences
  • Meal vouchers (95 CZK per worked day, 55% covered by the company)
  • Language trainings (EN, DE, FR, ES or CZ)
  • Multisport card (fully paid by the company)
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