Preclinical Safety Expert (Toxicology/Safety Pharmacology)

Grünenthal Group

Aachen , Germany

Your tasks and responsibilities:

  • Preparation of development plans for preclinical safety studies (toxicology and safety pharmacology) of drug candidates;
  • Support of preclinical teams with respect to toxicological and safety pharmacological studies/programs;
  • Conduct of preclinical GLP-safety studies at contract research organizations (CROs) as study monitor;
  • Scientific evaluation and interpretation of results from preclinical safety studies;
  • Presentation of results in preclinical teams and in front of senior management;
  • Preparation of toxicological expert statements for active substances, impurities and excipients;
  • Preparation and review of preclinical safety parts of regulatory documents (IND, CTD, IMPD, IB, briefing books etc.);
  • Responses to request form national and international agencies related to questions on preclinical safety studies.

Your qualification:

  • Completed study in veterinary medicine or natural science with academic degree;
  • Several years of experience in the pharmaceutical/biotechnology industry or a contract research organization in regulatory toxicology and or safety pharmacology;
  • Additional qualification as expert in toxicology would be desirable;
  • Knowledge of working under Good Laboratory Practice regulations and guidelines (ICH, EMA, FDA etc.) for preclinical development of drug candidates;
  • Excellent communications skills, team spirit and assertiveness;
  • Experience with self-contained working in multi-disciplinary teams;
  • Fluently in German and English speaking and writing.

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