République tchèque 22.04.2021

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) and non-interventional studies. Our offices are located in France, Belgium, Switzerland, Germany and Czech Republic.

Due to fast growth of our company we are currently recruiting a colleague for the position of Advanced Safety Officer, who will:
Manage the receipt, documentation and processing of clinical trial and post-marketing cases from assigned projects, with respect to regulations and applicable procedures. This includes, but is not limited to:

1. Entry of safety data into database(s) and tracking systems

  • Review of adverse events and special situations for completeness, accuracy and appropriateness for expedited reporting
  • Write narratives
  • Code adverse events accurately using MedDRA
  • Prepare the assessment of the expectedness/listedness against appropriate label
  • Identify clinically significant information missing from initial reports and ensures its collection
  • Ensure case receives appropriate steps, including medical review and submission when applicable, in timely manner, if the Safety Officer is the ‘Case Owner’
  • Ensure follow-up correspondence with reporters and medical reviewers accordingly
  • Report cases to clients, regulatory authorities, ethics committees, investigators and project personnel, if required and in timely manner, within project timelines specified in the Safety Data Exchange Agreements/Safety Plans
  • Maintain filing of cases (paper and/or electronically).

2. Participate in the preparation and writing of Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), Addendum to Clinical Overview (ACO).

3. Maintain a comprehensive understanding of AIXIAL or Clients’ Standard Operating Procedures (SOPs), instructions, guidance documents … and contribute actively to the development or revision of applicable quality documents for the department (procedures, instructions, templates).

Requirements

Minimum requirements:

  • Pharmacist or scientist in the medical and/or pharmaceutical domains
  • Very good English is mandatory, any other language is an advantage
  • Minimum of 2 years’ experience in pharmacovigilance (in activities such as case management, reconciliation, literature search, periodic reports preparation, etc.)

Additional Desirable Skills

  • Good organizational and prioritization skills
  • Good interpersonal skills (i.e. team player)
  • Working knowledge of MedDRA
  • Flexibility and ability to adapt and learn quickly
  • Ability to work under pressure and to tight deadlines
  • Excellent communication and presentation skills in English (both written and spoken)

We offer:

  • an opportunity to work in international team
  • flexible working hours with a possibility of home-office
  • young and friendly team
  • 25 days of holiday per year (instead of the standard 20 as per Czech law)
  • a possibility of professional courses and international conferences
  • 95 CZK Meal voucher (55% covered by the company)
  • Language trainings (options: EN, DE, FR, ES, CZ)
  • Multisport card (fully paid by the employer)
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SPONTANEOUS APPLICATION
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SPONTANEOUS APPLICATION








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