sprachenwechsel d 30x25

Medical Affairs

  • Support in all pharmacovigilance related matters of medicinal products
  • Compilation of Risk Management Plans (RMP)
  • Compilation of Periodic Safety Update Reports (PSURs)
  • Support in Medical Writing
  • Compilation / Revision / Upate of product information texts, such as SMPCs (Summary of Product Characteristics), PILs (Patient Information Leaflets) and texts for packaging materials and labelling
  • Preparation of Investigational Medicinal Products Dossiers (IMPD)
  • Preparation of Investigational Brochures (IBs)
  • Compilation of pharmacological-toxicological expert’s reports and clinical expert’s reports for medicinal products (CTD Module 2.4 - 2.7)
  • Compilation of Cosmetic Product Safety Reports (CPSR) for cosmetics
  • Literature search with relevance to drug safety issues and risk-benefit-assessments and in fulfilment of requirements of GVP, Module VI
  • Compilation of assessment reports and evaluations in support of combinational medicinal products containing more than one active pharmaceutical ingredient
  • Support with translations of product information texts and other medicinal texts, review of provided translations and implementation of necessary corrections
  • PIP compliance verification / PIP waiver documents
  • Evaluation and preparation of advisory requests at regulatory authorities (Regulatory Advice, Scientific Advice)
  • Compilation of briefing documents for consultations with health agencies
  • Compilation of environmental risk assessments (ERA)
  • Safety data exchange agreements
  • Support with translations of product information texts and other medicinal texts, review of provided translations and implementation of necessary corrections