Head of Global Drug Safety

Reference Number: 895644-W
Type of placement: Contract, 6+ Months

Introduction:

  • Develop and maintain the Global Drug Safety system according organizational processes, external (regulatory and legal) requirements and internal needs
  • Ensure that Global pharmacovigilance and risk management is meeting internal and external regulatory requirements and quality standards and is organized in an efficient manner for all investigational compounds in clinical development and for all marketed products

Main Responsibilities:

  • Develop and maintain the Global Drug Safety system according organizational processes, external (regulatory and legal) requirements and internal needs
  • Ensure that Global pharmacovigilance and risk management is meeting internal and external regulatory requirements and quality standards and is organized in an efficient manner for all investigational compounds in clinical development and for all marketed products
  • Chair the Drug Safety Committee
  • Establish and maintain the pharmacovigilance system for the company.
  • Provide oversight of the company Pharmacovigilance System and ensure its functioning in all aspects
  • Prepare reports for Competent Authorities of the EU Member States (as applicable)
  • Provide input where applicable to clinical study protocol writing (safety section) and labelling activities (sections: side effects, contraindications and warnings, interactions)
  • Ensure continuous overall pharmacovigilance evaluation during the post-authorisation period
  • Maintain overview of the safety profiles and any emerging safety concerns for all approved medicinal products and maintain overview on safety profiles and any safety concerns regarding all company’s investigational compounds
  • When requested, provide to Competent Authorities of any other information
  • relevant to the evaluation of the benefits and risks of company’s compounds
  • Act as the local drug safety contact point to the outsourced EU QPPV
  • Act as a local QPPV for Switzerland.

Qualifications and Experience:

  • Medical degree (MD or equivalent) or corresponding professional experience
  • 7 or more years experience in Drug safety in the Pharmaceutical industry
  • In-depth knowledge of  PV, GVP, ICH-GCP and other relevant standards and guidelines
  • Effective leadership skill to lead  teams
  • Fluent written and spoken English
  • Knowledge of German is also an advantage
  • Good computer knowledge
  • Team worker with high level skills in Integrity, flexibility & organization
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