Galderma Pharmacovigilance Associate Analytics Expert
hace 1 semana
About the Role:
The Senior PV Associate Analytics & Reporting will be responsible for implementing pharmacovigilance plans, processes, and policies related to the collection, assessment, and prevention of adverse effects following the use of our marketed or development products. They will ensure the quality of PV activities in R&D and Operations projects in accordance with GxP, local and international regulations, and guidelines.
Key Responsibilities:
- Reconcile, process, and communicate high-quality product safety data and analysis to internal and external stakeholders throughout the product life cycle.
- Implement and execute pharmacovigilance programs and policies with rapid identification and analysis of safety signals to inform emerging product safety profiles of all product types and drive patient safety risk management.
- Align and implement pharmacovigilance plans and activities to provide integrated strategic safety expertise and safety deliverables to product development programs.
- Administer relevant activities to control the quality and accuracy of the data used in product discovery and development programs.
- Prepare department quality documents and participate in quality audits and inspections.
Skills & Qualifications:
- Comprehensive knowledge of international PV regulations, standards, and principles for drugs, cosmetics, and medical devices.
- Good knowledge and extensive experience of aggregate reporting, risk management standards, and methodology and signal detection from the pharmaceutical/medical device industry.
- Good knowledge of the global vigilance and safety requirements for clinical development and registration process.
- Good knowledge of Microsoft Office suite of products and PV computerized systems.
What We Offer:
- A competitive compensation package with a salary range of $120,000 - $150,000 per year, depending on experience.
- A hybrid work culture that allows for flexibility and work-life balance.
- A growing company that believes in ownership from day one, where everyone is empowered to grow and take on accountability.
- Ongoing training and development opportunities to help you advance your career.
- A diverse and inclusive work environment that values diversity and promotes equality.
About Us:
Galderma is a leading global pharmaceutical company dedicated to delivering innovative solutions for dermatological conditions. We are committed to improving the lives of patients and caregivers worldwide through our passion for science and dedication to excellence.
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