République tchèque 05.04.2022

Junior 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 , Denmark, Sweden and Czech Republic.

Due to fast growth of our company we are currently recruiting a colleague for the position of Junior Safety Officer, to ensure the good performance of vigilance activities (pharmacovigilance, materiovigilance & medical devices, cosmetovigilance, nutrivigilance), of medical information and of writing periodic reports for research or authorized products.

The activities include (but are 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. Be under the supervision of the Head of vigilance, a Senior or Advanced Safety Officer/Physician on activities or projects requiring specific or technical expertise or experience.

3. Participate in the monitoring of regulations concerning Vigilance activities (pre- and post-marketing).

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



Requirements

What are we looking for?

  • Master’s/PhD degree (with at least 1 year of PV experience) or PharmD degree (no professional experience requested)
  • English on a fluent level (ability to run a meeting, technical vocabulary)

Additional Desirable Skills

  • Good organizational and prioritization skills
  • Good interpersonal skills (i.e. team player)
  • Working knowledge of MedDRA and pharmacovigilance database
  • 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
  • possibility to chose between working from Prague or Brno office
  • flexible working hours with a possibility of home-office
  • 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)

Does this sound exciting to you? If so, we look forward to meeting you!

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