Deputy Local Safety Officer

hace 3 días


Madrid, Madrid, España Daiichi Sankyo A tiempo completo
Job Title: Deputy Local Safety Officer

We are seeking a highly skilled and experienced Deputy Local Safety Officer to join our team at Daiichi Sankyo. As a key member of our Pharmacovigilance department, you will play a critical role in ensuring the safety of our products and compliance with regulatory requirements.

Key Responsibilities:
  • Act as the Deputy of the National PV Contact Persons in Spain and Italy, ensuring compliance with pharmacovigilance regulatory requirements.
  • Support the Local Safety Officer in performing/overseeing all local PV activities in Spain and Italy, including safety report collection and literature screening.
  • Liaise with local stakeholders, including Medical, Marketing, and PV vendors, to ensure PV processes are implemented properly.
  • Contribute to the maintenance of the EU Pharmacovigilance System Master File (PSMF) and the company's benefit-risk evaluation for Daiichi Sankyo products.
  • Act as a key contributor for GVP affiliate audits/inspections in Spain and Italy, and contribute to the enhancement of EU affiliates PV Quality Management System standards.
Requirements:
  • Previous experience in Pharmacovigilance activities in the Spanish PV affiliate, with experience in Italy being advantageous.
  • Bachelor's degree in Life Sciences, Pharmacy, or Medical Sciences with postgraduate qualification preferred.
  • Strong knowledge of International, European, and local PV laws and guidance.
  • Considerable pharma organization awareness, including experience working cross-functionally.
  • Fluency in Spanish, English, and Italian is a mandatory requirement.

We offer a dynamic and inclusive work environment, with opportunities for growth and development. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply.



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