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