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)