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Pharmacovigilance Specialist II

BioMarin Pharmaceutical Inc.

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Location: Novato, CA Posted Date: 4/12/2013 Position Type: Full time Job Code: 13-0012 Required Education: High school or equivalent

Description

BioMarin Pharmaceutical Inc.
At BioMarin, we recognize and value each employee’s contribution toward reaching our corporate mission—to develop and commercialize innovative biopharmaceuticals for serious diseases and medical conditions. To this end, we strive to provide employees with a work environment that supports their personal and professional growth. We value the spirit of teamwork and collaboration, encourage honest and open communication amongst all employees, and recognize and celebrate the successes that we work so hard to achieve. We hold ourselves to high standards, and we seek employees who expect excellence in themselves and those around them.

Today, with four products on the market and many other opportunities in our pipeline, there remains a lot of work to be done. We are committed to maintaining a motivated team and to providing a challenging and rewarding career opportunity for every individual who joins us.

EEO/M/F/D/V
To apply: Visit www.BMRN.com Job Code 13-0012

Manages the collection, processing and reporting of Adverse Events (AEs) for BioMarin investigational and post marketed products, and represent the Pharmacovigilance Department at BioMarin meetings, both internal and external.

RESPONSIBILITIES:
-Independently collects, processes and reports AEs from BioMarin clinical studies and post marketed products, in accordance with Standard Operating Procedures and FDA and ICH guidelines
-Perform initial reportability assessment, triage, distribution and notification, data entry, narrative generation, quality control review, follow up and submissions preparation.
-Author Analysis of Similar Events as needed
-Facilitates review of individual SAE reports by Medical Monitor and other BioMarin Clinical Operations and Regulatory Affairs staff as appropriate.
-Author and/or review periodic safety reports.
-Performs database reconciliation with appropriate Clinical Operations personnel. Responsible for Data Listings reviews and ongoing clinical coding review.
-Prepares reports on cumulative SAE data for clinical study team members and Regulatory Affairs.
-Represent Pharmacovigilance Department on project teams as assigned.
-Works with the Department, Regulatory Affairs, project teams, Contract Research Organizations (CROs) and consultants to ensure effective communication and coordination of work.
-Participates in the development and implementation of Pharmacovigilance policies and standard operating procedures.

To apply: Visit www.BMRN.com Job Code 13-0012

Requirements

EDUCATION:
Bachelor’s degree required preferably in a scientific field; RN, PharmD, or MD required

EXPERIENCE:
• Minimum of 2 years Drug Safety experience.
• Thorough knowledge of medical terminology essential.
• Working knowledge of MedDRA and WHO-DRUG
• Skill requirements: ability to work in a team environment, perform detailed analyses, meet tight deadlines, excellent writing skills, computer proficiency.

To apply: Visit www.BMRN.com Job Code 13-0012
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