today

Drug Safety Associate

NovImmune S.A.

  • Work region
  • Sector
  • Employment type
  • Position

Novimmune SA is a drug discovery and development company located in Plan-les-Ouates and Basel, Switzerland, that focuses on developing therapeutic monoclonal antibodies for inflammatory diseases and immune-related disorders.


 


The pipeline is a balance of preclinical and clinical compounds, specific for clinically validated and novel targets. Each of these portfolio products has the potential of becoming a medicine for multiple medical conditions due to the intrinsic mechanism of action. Five of these compounds are currently in early clinical development with the three most advanced in clinical Phase II. The company has also been purposefully targeting a number of orphan drug indications, with the express hope of eventually providing safe and effective treatment options to some of the often neglected populations suffering from rare diseases.

Drug Safety Associate

Novimmune SA is a drug discovery and development company located in Plan-les-Ouates and Basel Switzerland that focuses on developing therapeutic monoclonal antibodies for inflammatory diseases and immune-related disorders.

The pipeline is a balance of preclinical and clinical compounds specific for clinically validated and novel targets. Each of these portfolio products has the potential of becoming a medicine for multiple medical conditions due to the intrinsic mechanism of action. Five of these compounds are currently in early clinical development with the three most advanced in clinical Phase II. The company has also been purposefully targeting a number of orphan drug indications with the express hope of eventually providing safe and effective treatment options to some of the often neglected populations suffering from rare diseases.
Drug Safety Associate
Initial 6 months contract desired immediate availability Novimmune is seeking a Drug Safety Associate to work in our Plan-les-Ouates office with the Drug Safety department with regards to safety information and medical reviews in clinical trials for a drug candidate to combat cancer. This cancer medication is intended to fight cancerby luring the immune system to seek and destroy B cell tumors using antibody mediated immunotherapy.


Key Responsibilities


The Drug Safety Associate will participate in the preparation of Study Specific/Development Risk Management Plans and the safety sections of relevant study documents


Process adverse event reports from clinical trials


Monitors ongoing safety information provided by investigational sites and alerts for missing information


Review and perform consistent coding of adverse events as required


Supports the generation of Periodic Safety Reports e.g. 6m LL DSUR PSUR.. and other cumulative safety reports including data retrieval analyses and quality control


May support operational management of Data Monitoring Committee


Provide input in development of safety procedures and forms as well as administrative guidelines and processes



Skills and competencies



A life sciences/pharmacy/nursing degree with at least 3 years of professional experience in safety and clinical research in the pharmaceutical industry


Demonstrated experience in safety report submissions to ECs and competent authorities


Solid knowledge and understanding of US EU Pharmacovigilance regulatory requirements and MedRA coding


Ability to interact effectively in a multifunctional and multicultural team setting


Experience with safety database


Excellent written and verbal communication skills detail oriented


Computer proficiency especially in Microsoft Word Excel PowerPoint


Relevant working/residency permit or Swiss/EU-Citizenship required

Chemin des Aulx 14 1228 Plan-les-Ouates