Pharmacovigilance Associate II

About the role

The Pharmacovigilance Associate II will play a key role in the monitoring and management of adverse event reporting for BioMarin's pharmaceutical products. This individual will work closely with cross-functional teams including Medical Affairs, Regulatory Affairs, and Sales to ensure global compliance with pharmacovigilance regulations.

Responsibilities

• Manage the collection, evaluation, and reporting of adverse events and other safety data
• Collaborate with cross-functional teams to ensure timely and accurate submission of reports to regulatory authorities
• Support the development and implementation of pharmacovigilance strategies and processes
• Participate in risk assessment activities to identify potential safety issues and implement mitigation plans
• Provide training and support to colleagues on pharmacovigilance best practices and regulatory requirements
• Stay current with pharmacovigilance guidelines and regulatory changes

Requirements

• Bachelor's degree in a relevant field such as pharmacology, pharmacy, or a related life sciences discipline
• Minimum of 5 years of experience in pharmacovigilance or a related field
• Experience with pharmacovigilance software systems such as MedWatch, VigiBase, or similar platforms
• Strong knowledge of pharmacovigilance regulations and guidelines, including ICH E2A, E2B, and E2C
• Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment
• Ability to manage multiple tasks and prioritize responsibilities effectively

Qualifications

• Proven track record in pharmacovigilance and safety monitoring
• Experience with pharmacokinetic/pharmacodynamic modeling and simulation tools is a plus
• Knowledge of pharmacogenomics and pharmacoeconomics is beneficial

Skills

• Strong analytical and problem-solving skills
• Excellent attention to detail and accuracy in data management
• Proficient in Microsoft Office Suite, particularly Excel and PowerPoint
• Ability to communicate complex information clearly and concisely

Benefits

• Comprehensive health insurance coverage
• Flexible work schedule
• Professional development opportunities
• Employee wellness programs
• Generous paid time off

Pay

• $80,000 - $100,000 annually

Schedule

• Full-time