Safety Evaluation and Risk Management - Safety Physician

    • Siena, Italy

Site Name: Italy - Siena
Posted Date: May 4 2020
The Vaccine Clinical Safety and Pharmacovigilance department at GSK Vaccines, Italy, is looking for a

Safety Evaluation and Risk Management - Safety Physician

Role Summary
To actively manage and evaluate risks associated with assigned vaccine projects and make recommendations for the management and communication of risks in accordance with global legal and regulatory frameworks to deliver the following:

  • Coordinate and perform the medical analysis of adverse event reports and/or signal detection activities for assigned vaccine projects in clinical development and post-licensure
  • Be the safety contact person for Clinical, Regulatory Affairs and Local Operating Company safety managers, manufacturing teams for assigned vaccine projects
  • Provide medical input to Clinical Teams with respect to safety aspects of the design and preparation of protocols, investigators brochures, investigator letters and reports, for the follow up and processing of clinical study data and lead the safety analyses of the assigned projects.
  • Ensure creation, maintenance and implementation of Development, Core Safety Information for the assigned projects.
  • Ensure provision of the Benefit Risk Assessment and risk identification, assessment and mitigation activities for assigned vaccine projects

Your responsabilities :
  • Perform medical review of reported cases and provide medical advice on safety-related aspects associated with the assigned vaccines.
  • Provide appropriate and timely Benefit Risk Assessments for assigned vaccine projects within applicable regulations
  • Design, tracking and follow up of risk management plans for the products assigned and assure their sound implementation.
  • Lead the cross-functional Safety Review Team for assigned vaccine projects
  • Answering and follow-up of enquiries from regulatory authorities and other bodies (e.g., Ethics Committees) regarding safety-related aspects
  • Contribution to the development and revision of assigned central pharmacovigilance processes and related trainings.

Qualifications:

We are looking for professionals with these required skills to achieve our goals:
Medical Doctor with at least 2 years of experience in Clinical Safety and Pharmacovigilance, preferably in the area of Vaccines
  • Minimum 4 years of experience in the Pharmaceutical or Biotech industry working in Clinical Development, Drug Safety and Pharmacovigilance.
  • Post-graduate clinical practice (such as in Infectious diseases, Pediatrics and/or Internal medicine) would be a plus
  • Knowledge of Pharmacovigilance and signal detection tools, analysis and reporting of medical safety issues for vaccines, according to worldwide regulatory requirements.
  • Excellent mastery of English, written and spoken with strong communication and influencing skills. (Knowledge of Italian language would be a plus)
  • Strong leadership and collaborative working skills
  • Computer literate, familiar with using scientific and clinical databases.
  • Good administrative skills, analytical mind.
  • Integrity and strong feeling for ethics.

The position is based in Siena (Italy)
We encourage all interested candidate to apply without delay and we thank you in advance for your interest in this opportunity

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