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Senior PV Associate Analytics
hace 1 mes
Job Summary
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. This role 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.
Requirements
- 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
- You will be working for an organization that embraces diversity & inclusion and believes we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
- You will receive a competitive compensation package with bonus structure and extended benefit package.
- You will be able to work in a hybrid work culture.
- You will participate in feedback Loops, during which a personalized career path will be established.
- You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take on accountability.
