Advanced Pharmacovigilance Specialist
Há 3 dias
The Pharmacovigilance Specialist will be responsible for ensuring the quality management of all procedures, implementing audit findings and pharmacovigilance improvement projects in Latin America.
This role will participate in ongoing mapping of implemented processes and review control of documents to maintain direct communication with the EU-QPPV. The Pharmacovigilance Specialist will ensure compliance with Latin America regulations, local, regional and international legislations and global pharmacovigilance policies.
Additionally, this position will operate routine pharmacovigilance post-marketing surveillance in Latin America through review and submission to Global Pharmacovigilance (Corporate) of adverse event reports.
Key responsibilities include:
- Implementing, elaborating, reviewing and approving pharmacovigilance procedures related to Latin America.
- Reviewing and ensuring implementation of pharmacovigilance training post-marketing surveillance to all employees of Galderma Brazil, Latin America LSOs and Regional PV Staff.
- Elaborating and reviewing documentation for periodic pharmacovigilance reports, Pharmacovigilance Plan and Risk Minimization Plan when necessary.
- Notifying and reviewing spontaneous reports of drug adverse events to all Health Authorities in Latin America with Galderma Affiliate via an electronic form on the regulatory agency website.
This position requires a strong background in pharmacovigilance, preferably 5-7 years of experience in the field. Key skills and qualifications include:
- Strong verbal and written communication skills.
- Fluent in English and Spanish.
- Conduct of Pharmacovigilance legislation, Technovigilance, NOTIVISA and CVS.
- Professional education in the area of health with experience in pharmacovigilance.
- Mid-senior level professional with ability to work independently and as part of a team.
As a member of our team, you will have access to:
- A dynamic and supportive work environment.
- Opportunities for professional growth and development.
- A competitive salary and benefits package.
Join us in advancing dermatology for every skin story because we understand that the skin we're in shapes our life stories.
How to ApplyIf you are a motivated and experienced pharmacovigilance professional looking for a new challenge, please submit your application. We look forward to hearing from you.
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