République tchèque 09.06.2022

Junior Safety Physician

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, Scandinavia and Czech Republic.

We are currently looking for a Junior Safety Physician, who will:

  • Review all appropriate safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature).
  • Conduct medical assessment of all safety related data (AEs, SAE, SUSAR, AESI etc.).
  • Ensure medical accuracy of case narratives, coding and medical sense of all cases and ensures appropriate queries are raised to expedite case closure.
  • Write safety section, including benefit risk assessment of all aggregate safety reports such as Periodic Drug Safety Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), DSUR/IND Annual reports and line listings of Suspected Unexpected Serious Adverse Reactions (SUSARs) for regulatory submission.Prepare and may present product safety issues at meetings, both internal and external.
  • Author/review relevant sections of all aggregate safety reports and ensures the overall quality of documents.

Requirements

Who are we looking for?

  • Doctor of Medicine, without required professional experience
  • Fluent in English, written and spoken
  • Productive and diplomatic towards clients, collaborators and case reporters. Good relational capacity and communication skills
  • Clear ability to select the relevant information to be reported
  • Prior experience in Pharmacovigilance and medical writing is an advantage
  • Knowledge of MeDRA coding is an advantage

We offer:

  • An opportunity to work in international growing team
  • Interesting job tasks in the field of clinical trials
  • Flexible working hours with a possibility of home-office
  • Possibility to work from either Brno or Prague offices
  • 25 days of holiday per year
  • 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
  • Adequate salary
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