Drug Safety Team Leader

hace 2 semanas

Madrid Centro, Madrid, España Insud Pharma A tiempo completo
Job Title: Drug Safety Team Leader

At Insud Pharma, we are seeking a highly skilled and experienced Drug Safety Team Leader to join our Pharmacovigilance team. As a key member of our team, you will be responsible for ensuring legal and regulatory compliance with pharmacovigilance regulations and Good Pharmacovigilance Practices (GVP).

Key Responsibilities:
  • Coordinate the activities related to the Pharmacovigilance System, Quality Management System, and safety from clinical trials.
  • Act as Deputy Qualified Person Responsible for Pharmacovigilance (Deputy QPPV) and be responsible for the pharmacovigilance system in the absence of the QPPV.
  • Collaborate in the maintenance of the Pharmacovigilance System Master File and ensure readiness for audits and inspections.
  • Collaborate in the maintenance of the Quality Management System and provide support in the elaboration and update of Global Standard Operating Procedures (SOPs).
  • Active collaboration on pharmacovigilance activities related to clinical investigation, including reviewing and managing safety in clinical protocols, organizing DSUR, and reconciliations with CRO.
  • Collaborate in the Signal Committee and signal detection processes.
  • Ensure proper preparation, review, and submission of safety reports, including PSUR, RMP, and renewals.
  • Supervise the implementation of additional risk minimization measures (aRMM) and collaborate in the coordination of response to health authorities.
  • Supervise the implementation of training programs and ensure proper training of employees.
  • Supervise the elaboration, management, follow-up, and implementation of PV contracts and agreements with third parties.
  • Keep PV files safe, accurate, updated, and complete, in compliance with internal standards and applicable regulations.
  • Collaborate on vigilance activities related to medical device incidents, including management of cases, evaluation, submission, and archive.
Requirements:
  • University Degree in Health Sciences (Pharmacy, Medicine, Odontology) or a related field.
  • Fluent English and Spanish, with knowledge of other languages an asset.
  • At least 1 year of experience in similar positions and at least 5 years of experience in a Pharmacovigilance department in a medium-large pharmaceutical company.
  • Expertise in Pharmacovigilance, national and European legislation related to pharmacovigilance, and knowledge on European Pharmacovigilance System (EVWEB/EVDAS).
  • Willingness to travel less than 5%.
What We Offer:

At Insud Pharma, we offer a dynamic and challenging work environment, with opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.

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