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Senior Safety Advisor
Il y a 2 mois
Capijobnew is seeking a highly skilled Senior Safety Advisor to join our team. 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 a Project Manager, providing a priority interface with clients, supporting the development of SDEAs, tools, and documents, and participating in client meetings.
- 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.
- 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).
- 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.
