République tchèque 22.04.2021

Advanced Safety Officer


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).


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)


    AIXIAL informs you that the data we have gathered in this form is indispensable to manage the recruitment process involving the computer processing of your personal data. The collected data may be forwarded to the Group's various entities for the same purposes.
    We remind you that you have a right of access, correction and deletion for the data relating to you, a right of limitation, portability, erasure and opposition for legitimate reasons that you may exercise by sending an email to our DPO at the following address : dpo-france@aixial.com.
    Your personal data is intended for the authorized departments of AIXIAL and it will be retained for a period of 2 years as from our final contact.
    For further details, please consult the AIXIAL Privacy Policy : Data protection policy