Pharmacovigilance Associate II

About the Company

BioMarin Pharmaceutical Inc. is a worldwide biotechnology organization focused on advancing human health through bold scientific research and genetic innovation. Since 1997, the company has used deep expertise in genetics and molecular biology to develop medicines for serious genetic conditions and unmet medical needs.

The organization builds a team of technically strong, highly driven professionals and fosters an environment that supports innovative problem-solving across discovery, clinical, and commercial programs.

Role Overview

The Pharmacovigilance function is responsible for actively monitoring product safety across the full product lifecycle, responding quickly to new validated safety information, and maintaining global pharmacovigilance compliance. In this role, the Associate II supports case handling, data entry, quality review, and regulatory submissions for non-expedited individual case safety reports.

This position calls for strong communication, teamwork, initiative, sound judgment, and the ability to solve workflow challenges effectively.

Key Duties

• Track incoming safety information through the BPV inbox and Argus safety database throughout the business day.
• Review each incoming item promptly, assess validity using source documents, check for duplicates, and open initial case records in the safety database according to established procedures.
• Enter data for all non-serious ICSRs as well as serious, non-expedited ICSRs, while keeping within required timelines.
• Prioritize the oldest pending cases first and ensure all open actions are completed; use email classification tools to sort and rank incoming work.
• Handle follow-up cases and previously reported events.
• Confirm case receipt by sending acknowledgment messages and sharing pharmacovigilance case numbers with relevant partners.
• Complete quality checks by comparing source documents against database entries to verify completeness and accuracy.
• Assist with submissions to regulatory agencies and business partners, including support for cover letters and IND safety report Form 1571 preparation, and help resolve submission issues when they arise.
• Reconcile safety data between vendor or partner databases and the pharmacovigilance safety database.

Additional Information

The job description is meant to outline the general scope of the position and may include additional responsibilities as assigned.

Equal Opportunity Statement

BioMarin is an equal opportunity employer. All qualified applicants are considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.