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.
o Perform initial reportability assessment, triage, distribution and notification, data entry, narrative generation, quality control review, follow up and submissions preparation.
- 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 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.
Bachelor’s degree required preferably in a scientific field; RN, or PharmD, preferred.
- 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