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
o Perform initial reportability assessment, triage, distribution and notification, data entry, narrative generation, quality control review, follow up and submissions preparation.
o Author Analysis of Similar Events as needed
o 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.
EDUCATION
Bachelor’s degree required preferably in a scientific field; RN, or PharmD, preferred.
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.
CareerTopJobs.com - 3 years ago
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