Director Pharmacovigilance Safety Systems

About Madrigal:
Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.
Role Overview:
Director Pharmacovigilance Safety Systems
The focus for this position is to optimize global safety systems.  This role will also be responsible for setting PV technology strategy, looking for opportunities for efficiency and innovation
Position Responsibilities: 

• Strategically lead PV systems management, ensuring alignment with global regulatory requirements.
• System Management: Ensure the proper implementation, maintenance, and enhancement of pharmacovigilance systems and databases to support drug safety operations which also includes setting the outsourcing strategy with management approval
• Vendor Management: manage the identification and oversight of the safety system vendor including monitoring of Key Performance Indicators to ensure high-quality service and regulatory compliance.
• Regulatory Compliance: Ensure all pharmacovigilance activities comply with global regulatory requirements, including FDA, EMA, and other relevant regulatory bodies. By ensuring safety system (e.g. Argus) is properly configured and validated to function as designed.
• Data Analysis: 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 enhancement and use of AI as appropriate.
• Stakeholder Collaboration: 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 and Skills Required:

• Education: Degree in computer science, Life Science or a related field.
• Experience: Minimum of 10 years of experience in computer systems with at least 5 years in pharmacovigilance managing safety systems and operations.
• Technical Skills: Expertise in pharmacovigilance safety databases (e.g. Argus, ARISg etc), safety reporting systems, and data analysis tools.
• Regulatory Knowledge: In-depth knowledge of global pharmacovigilance regulations and guidelines, including ICH, FDA, and EMA requirements.
• Analytical Skills: Strong analytical and problem-solving skills, with the ability to interpret complex safety data requests and make translate those to obtain necessary system outputs to allow safety decision making
• Communication Skills: Excellent written and verbal communication skills, with the ability to effectively communicate
• Experience managing vendor relationships and ensuring high-quality service delivery

Compensation:
Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.