Pharmacovigilance Associate II

Responsibilities

• Monitor the BPV Inbox and Argus safety database for receipt of safety information.
• Review incoming items and source documentation to assess case validity and check for duplicates.
• Initiate initial reports into the safety database according to appropriate work instructions.
• Perform data entry for all non-serious ICSRs and all serious, non-expedited ICSRs.
• Process follow-up cases and previously reported events while ensuring all timelines are met.
• Conduct quality reviews of source documentation to ensure data accuracy within the safety database.
• Support regulatory submissions, including reports to authorities and business partners.
• Conduct reconciliation of vendor and partner safety databases with the internal Pharmacovigilance safety database.

Requirements

• BA/BS degree in health or life sciences (relevant experience in lieu of education may be accepted).
• 3+ years of pharmacovigilance experience.
• Proficiency with the Argus safety database.
• Experience with data entry for ICSRs and quality review of source documentation.
• Strong communication skills and the ability to work collaboratively within a team.
• Ability to act proactively and effectively respond to workflow challenges.

About the Company

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines for patients with significant unmet medical need.