Drug Safety Officer, Aurealis Therapeutics – Adecco, Kuopio
17.11.2023https://www.linkedin.com/jobs/view/3752455006
About the job
Are you looking for new career opportunities in the field of cell and gene therapies? Are you passionate about developing patient safety? Great! A warm welcome to be a part of the biopharmaceutical success story and making better tomorrow. We are all in this – together!
We are now looking for an experienced Drug Safety Officer to our partner Aurealis Therapeutics for a permanent employment to be responsible for the drug safety management. You can be located at Kuopio or elsewhere in Finland, there is a possibility for working remotely.
In your position, you play a key role ensuring patient safety and be responsible for the safety aspects of the clinical development program. You work closely with CRO teams, sponsors, trial sites and your own team. Your responsibilities include drug safety and pharmacovigilance related advice and consulting, safety updates and reporting. You are also responsible for keeping up to date on all the applicable regulations and updating internal SOPs. You analyze and interpret information and check whether the medical and surgical history, concomitant medications and adverse events are coded and reported properly. Your responsibilities also include coordinating and establishing a global safety database together with external service providers, advisors, and consultants. You will work as a part of a dynamic team of 12 people and report to CMO (Chief Medical Officer).
The start date of the job is negotiable, but we wish you could start during the last quarter of calendar year 2023. You will be working full-time.
In order to succeed you will need to have:
- 2+ years previous experience in similar roles
- Practical experience and understanding of drug development process in the field of clinical drug research, clinical trials and monitoring as well as drug safety and pharmacovigilance.
- Degree in related field, e.g.,life sciences, healthcare, pharmacology
- Deep knowledge of relevant regulations e.g., ICH/GCP/GVP and EMA, knowledge of FDA guidelines is advantage.
- Experience working with CRO teams (external service providers)
- Excellent organizational, decision-making, cooperation, and project management skills
- Strong verbal and written communication skills (English)
Experience in chronic wound indications, medical coding (e.g. MedDRA, WHODrug) and working with safety database and EDC is considered as an advantage but are not a must. You are a true team player who can hold all the threads of a project in your hands and are experienced in prioritization which is needed in a small company environment. You thrive in changing situations and enjoy challenges. You will have an opportunity to influence your role, as the job description can be modified according to your skills.
What Aurealis Therapeutics offers you
A challenging, versatile and meaningful role in international and dynamic working environment where you can truly develop in your career path. In your positions, you play a key role ensuring patient safety. Position is new, so you have a great opportunity to create your own role according to your skills. At Aurealis, everyone’s work input, creativity and rigour are greatly appreciated. You have the freedom to determine your own working methods and bring development ideas and solutions to the table. The work community is close-knit and warm-hearted, which is reflected in an excellent team spirit. Collective agreement for white-collar works in the chemical industry (Kemianteollisuuden toimihenkilöiden työehtosopimus) applies to employment relationship and the salary is determined according to your skills and experience.
In addition to an encouraging salary, you get comprehensive personnel benefits, such as extensive occupational healthcare services, leisure accident insurance, a bicycle benefit, encouraging Smartum benefits (support for physical and cultural free-time activities), free parking and you get access to company’s option and bonus model.
The application process and selections
Send your application and resume via the attached application link by 19.11.2023 at the latest and tell us why you would be the most suitable person for the position. Please note that we are processing applications within the application period. Adecco Finland is responsible for the recruitment process. You will be employed directly to our partner Aurealis Therapeutics for a permanent employment. For more information, please contact Adecco’s Recruitment Consultant Heidi Hämäläinen primarily by email Heidi.hamalainen@adecco.fi (tel. 040 558 9342.)
Aurealis Therapeutics is a Swiss-Finnish private biopharmaceutical company focusing on the development of a 4-in-1 synthetic biology, cell and gene therapy platform to address unmet medical needs in three therapy areas: chronic wounds, oncology, and inflammation. Aurealis Therapeutics is located in Kuopio, Finland and in Basel, Switzerland. Aurealis genuinely want to create game-changing therapies that help patients and improve their quality of life – this is matter of hearts. Aurealis value people and a dignified life, and this is also the core of the culture: Appreciation and trust in everything they do. We are all in this – Together!
Read more: https://aurealistherapeutics.com/
keywords: biopharmaceutics, patient safety, drug safety, pharmacovigilance, clinical drug research, clinical development, clinical trials, drug development, biolääketiede, potilasturvallisuus, lääketurvallisuus, lääkevalvonta, kliininen lääketutkimus, kliininen kehitys, kliiniset kokeet, lääkekehitys.
Posted on Nov 2, 2023.