Pharmacovigilance Associate

Chiltern Ver Empresa

Não especificado
Licenciatura

Chiltern is the leading, global mid-sized contract research organization. We listen to client needs to deliver customized clinical development solutions with a team of more than 4,300 working across 47 countries to provide comprehensive, yet flexible and responsive, services. Our specialties include clinical development, Oncology, Devices and Diagnostics, Data, Analytics & Evaluation and Strategic Service Provision.

Chiltern is looking to recruit a Pharmacovigilance Associate office based in Lisbon to be dedicated to one of our sponsors, a global pharmaceutical company.

This position is permanent full time.

DUTIES & RESPONSIBILITIES

  • Manage collection, processing, documentation, reporting and follow-up of all adverse event reports from clinical trials, non-interventional studies, Patient Oriented Programs, literature, Spontaneous Reports, etc.
  • Manage reporting/submission/distribution of safety reports/updates/information (e.g. SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities and/or clinical operations.
  • Survey and monitor national pharmacovigilance regulations and provide update to global organization.
  • Develop, update and implement local procedures to ensure compliance with global procedures and national requirements.
  • Perform reconciliation with other departments (e.g. Medical Information, Quality Assurance and third party contractor, if applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources.
  • Management and maintenance of all relevant Safety databases.
  • Develop and update training materials for pharmacovigilance and ensure training of country colleagues on relevant procedures for AE reporting (including field force and third party contractor, if applicable).
  • Ensure support for audits, corrective action plan, and investigation and Health Authority inspections.

REQUIREMENTS

  • At least 2 – 3 years experience in a similar role are required.
  • Excellent verbal and written communication in English.
  • Ability to understand various key stakeholders and customers to respond appropriately.
  • Ability to work effectively in a team environment.
  • Ability to plan, organize, prioritize, and execute multiple tasks within assigned objectives.

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