Senior Safety Advisor

il y a 2 jours


Cannes, Provence-Alpes-Côte d'Azur, France Capijobnew Temps plein
Job Title: Senior Safety Advisor

We are seeking a highly skilled Senior Safety Advisor to join our team at Capijobnew. As a Senior Safety Advisor, you will be responsible for ensuring the good performance of post-marketing pharmacovigilance projects, in accordance with contracted specifications, regulations, ethics, quality, and compliance with procedures and deadlines.

Main Responsibilities:
  • Manage projects as Project Manager, providing a priority interface with clients, supporting the development of SDEAs, tools, and documents, and establishing work plans.
  • Manage Adverse Events for assigned projects, in accordance with applicable regulations and procedures.
  • Conduct global and local literature surveys concerning entrusted products and corresponding pathologies.
  • Participate in monitoring of regulations for Vigilance activities (pre- and post-marketing).
  • Prepare Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), Addendum of Clinical Overview (ACO), and Signal detection.
  • Participate in preparation and attendance of audits and inspections, as well as in the implementation of corrective or preventive action of CAPAs.
  • Theoretical knowledge and practical skills in MedDRA and WHO DD coding.
  • Participate in definition of human resources needs for projects on which you are assigned in consultation with the Head of the department.
Requirements:
  • A university degree in Pharmacy, health science, medicine, or a related discipline.
  • 4 to 6 years of relevant experience in pharmacovigilance.
  • Experience of work in a multinational company.
  • Good knowledge of regulations (GVP, ICH, GCP) and tools related to the activity (databases, Eudravigilance).
We Offer:
  • An opportunity to work in an international team.
  • An attractive finance bonus according to good results.
  • A young and friendly team.
  • 25 days of holiday per year.
  • Pleasant offices in the center of Brno or Prague.
  • A possibility of professional courses and international conferences.
  • Meal vouchers.
  • Language trainings.
  • Multisport card.

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