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PATIENT SAFETY SPECIALIST

Vilnius - UAB "Simplika"

Job Purpose

  • To provide technical/administrative support to Patient Safety management team in activities such as preparation of documents for further processing, review, expediting and final archiving.
  • To support operational processes at Country Organization (CO) in ensuring compliance with company global/local procedures, national and international regulations/standards/guidelines for pharmacovigilance and medical device vigilance of company products (drugs and devices).

Responsibilities

  • Manage collection, processing, documentation, reporting and follow-up of all adverse event/incident reports data for all company products according to the defined timelines and quality parameters;
  • Perform reconciliation with other departments for potential adverse events;
  • Prepare the respective submission documents to Competent Authorities;
  • Ensure correct data entry in the global Patient Safety database;
  • Ensure training and oversight of staff in safety area;
  • Ensure compliance with support of the Functional Manager;
  • Monitor for any pharmacovigilance and medical device vigilance specific regulatory changes at country level.

Requirements

  • Bachelor’s degree (or equivalent) in Health Care Sciences or relevant work experience;
  • Knowledge of national and international regulations for pharmacovigilance, medical device vigilance;
  • Fluent English and Lithuanian both spoken and written;
  • Excellent communications, interpersonal and negotiation skills;
  • Experience on similar position in drug safety, medical device vigilance, drug registration or clinical research department would be an additional asset;
  • Quality and focus oriented;
  • Computer technical skills (e.g. Excel, Word, Power Point), experience in working with different databases.
CVB client

UAB "Simplika"

CVO Recruitment is an international recruitment company engaged in search and selection of professionals and top level managerial roles through CVO Finance, CVO Sales & Marketing and CVO Technology across the Central and Eastern Europe. In Lithuania we successfully operate for 15 years and have had many opportunities to enjoy our clients and candidates success.

Our client is a multinational and one of the largest pharmaceutical company.

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