Pharmacovigillance Specialist

Basic qualifications:

  • Medical doctor or pharmacist (relevant clinical or industry experience at least 2 years)
  • Good presentation and medical writing skills
  • Fluent oral and written English
  • Good PC skills

Preferred qualifications:

  • Medical knowledge: all basics relevant to anatomy, physiology, chemistry and biochemistry, pathology, therapeutics, surgery.
  • Good writing skills: ability to create comprehensible, comprehensive, grammatical texts.
  • Communication skills: ability to transfer and explain knowledge to medics, laypersons and colleagues.
  • Personal accountability, organization and accuracy
  • Strong ability for self-development
  • Interpersonal understanding and relationship building
  • Planning and concern for order

Details:

Pharmacovigilance team and entirely responsible for Pharmacovigilance support for CH products, marketed by GlaxoSmithKline Healthcare (Consumer Health) in accordance with common SOPs and Shared Service Agreement.

  • Receipt, investigation, collection and reporting of human safety information to GSK Central Safety Department.
  • Timely submission of individual cases and periodic safety reports to Regulatory Authorities, Investigators and Ethics Committees if required.
  • Maintenance and reconciliation of the appropriate databases and registries (product complaints, medical Information, others) used in Local Operating company with local AE cases.
  • Provision metrics for Central Safety Department and other stakeholders.
  • Provision information on request to Central Safety Departments and functions and for local Regulatory Authorities
  • Local point of contact for Regulatory Agencies for Pharmacovigilance-related topics for CH products.
  • Provision of PV training for CH employees in line with GSK requirements (Sales Forces, office-based employees with specific PV responsibilities, others)
  • Input in creation and maintenance of the local PV-related procedural documents
  • Participation in PV audits and inspections for CH products
  • Pharmacovigilance activities for licensing deals, for the 3d parties providing Pharmacovigilance services and for commercial activities which might generate human safety information.

Implementation of quality management system in Pharmacovigilance processes for CH products (self-inspections, risk identification, CAPA creation and management).

Contact information:

You may apply for this position online by selecting the Apply now button.

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