Director PV Safety Systems

I am partnered with an industry leading biopharma on a search for a Director Safety Systems, reporting into the VP, Drug Safety.

This innovative bio-pharmaceutical company is dedicated to developing groundbreaking treatments for metabolic and liver diseases. Their research focuses on creating therapies that address significant unmet medical needs, aiming to improve the quality of life for patients worldwide. With a strong commitment to scientific excellence and patient care, they are at the forefront of advancing medical science in their field.

This position focuses on optimizing global safety systems and setting the strategy for PV technology, seeking opportunities for efficiency and innovation.

Responsibilities:

• Lead PV systems management strategically, ensuring alignment with global regulatory requirements.
• Oversee the implementation, maintenance, and enhancement of pharmacovigilance systems and databases to support drug safety operations, including setting the outsourcing strategy with management approval.
• Manage the identification and oversight of the safety system vendor, including monitoring Key Performance Indicators to ensure high-quality service and regulatory compliance.
• Ensure all pharmacovigilance activities comply with global regulatory requirements, including those of the FDA, EMA, and other relevant regulatory bodies, by ensuring the safety system (e.g., Argus) is properly configured and validated to function as designed.
• Assist in the collection, analysis, and interpretation of safety data from various sources, ensuring accurate and timely reporting of adverse events by obtaining accurate outputs from the safety system.
• Identify and drive continuous improvements in PV operations through innovative technology solutions, process enhancements, and the use of AI as appropriate.
• Collaborate with internal and external stakeholders, including clinical development, regulatory affairs, and other internal departments, to ensure effective communication and coordination of safety information.

Qualifications:

• 10+ years of experience in computer systems, with at least 5 years in pharmacovigilance managing safety systems and operations.
• Expertise in pharmacovigilance safety databases (e.g., Argus, ARISg), safety reporting systems, and data analysis tools.
• In-depth knowledge of global pharmacovigilance regulations and guidelines, including ICH, FDA, and EMA requirements.