Pharmacovigilance Specialist I - Remote Opportunity

About the Role

We are seeking a dedicated Pharmacovigilance Specialist I to join our team at B. Braun Medical Inc. This remote position offers an exciting opportunity to contribute to the safety and efficacy of our pharmaceutical products. As a Pharmacovigilance Specialist I, you will play a crucial role in monitoring and evaluating adverse events, ensuring the highest standards of patient safety.

What You'll Do

• Receive and process incoming adverse event reports for B. Braun pharmaceutical products.
• Monitor and evaluate complaints for potential Adverse Drug Experiences (ADEs) and Adverse Drug Reactions (ADRs).
• Initiate Medical Assessments (MA) of events, including coding using MedDRA classification.
• Manage and file Product Incident Reports.
• Process and evaluate expedited and non-expedited ADE reports to the FDA, ensuring completeness and accuracy.
• Provide adverse event information for inclusion in aggregated reports, including Periodic Adverse Drug Experience Reports (PADER) and Signal Detection Reports.
• Work non-standard schedules as needed to meet reporting requirements.

Requirements

• Bachelor's degree required or equivalent combination of education and experience.
• 0-2 years of related experience in pharmacovigilance or a similar field.
• Basic knowledge of relevant business practices and procedures.
• Ability to work under general supervision and rely on experience and judgment to plan and accomplish assigned goals.
• Strong communication skills for interaction with department supervisors and external contractors.

Nice to Have

• Industry/professional certification in pharmacovigilance.
• Experience with MedDRA coding.
• Familiarity with FDA and Health Canada reporting requirements.

What We Offer

• Competitive salary range of $65,000 - $75,000 per year.
• Comprehensive healthcare benefits.
• 401(k) plan with company match.
• Tuition reimbursement for further education.
• Remote work flexibility to support work-life balance.