18 oct
|
Galderma
|
Barcelona
18 oct
Galderma
Barcelona
Global PV Associate - Analytics & Reporting
At Galderma, we're unique and we embrace difference. As the leading dermatology company in the world, we offer a broad portfolio of products across Aesthetics, Consumer Care and Prescription Medicine. Join us to make a direct impact and help shape the future of dermatology.
We are looking for a
Global PV Associate - Analytics & Reporting
to support pharmacovigilance activities for our integral portfolio of marketed medicinal and cosmetic products, ensuring patient safety, regulatory compliance and effective post-marketing safety surveillance.
Key Responsibilities
- Perform routine global pharmacovigilance activities, including aggregate reporting, signal detection and management, literature monitoring, and risk management.
- Lead and coordinate the preparation and review of aggregate safety reports, ensuring scientific quality, accuracy and compliance with applicable regulations and timelines.
- Provide scientific oversight of external pharmacovigilance service providers.
- Support regulatory submissions,
marketing authorisation maintenance and responses to requests from health authorities.
- Contribute as a subject matter expert to upgrades and improvements of pharmacovigilance databases and tools.
- Prepare and maintain departmental quality documents, support process improvements and contribute to operational excellence.
Ideal Profile
- Degree in Pharmacy or another relevant scientific discipline, with at least five years of experience in life sciences.
- Significant experience in pharmacovigilance, particularly post-marketing safety activities at a global or headquarters level.
- Strong knowledge of post-marketing pharmacovigilance regulations for medicinal products, with an understanding of relevant cosmetics regulations and industry best practices.
- Extensive experience in aggregate reporting, risk management methodologies and signal detection for medicinal products.
- Experience collaborating with external service
📌 PV Associate Analytics (Barcelona)
🏢 Galderma
📍 Barcelona