Clinical Research Associate

The Pharmacoviglance Specialist/Sr. Pharmacovigilance Specialist is responsible for the processing of adverse event information from all sources including clinical trials, post-marketing and published literature. This individual will also be responsible for the preparation of aggregate reports including PSURs, ASRs, DSURs and US Periodic Reports. Additionally, he/she will serve as pharmacovigilance resource to Clinical Development Teams.

Specific Responsibilities Include (but are not limited to):
Collect and process incoming adverse event reports from all sources
Perform initial assessment of seriousness, expectedness, causality, and reportability
Complete and QC data entry of incoming reports
Identify missing or discrepant information and perform active follow-up
Prepare expedited reports for submission to regulatory authorities and ethics committees
Serve as pharmacovigilance resource to Clinical Development Teams
Collaborate with clinical development staff on technical and scientific issues regarding SAE and SUSAR reporting
Work closely with safety physicians
Coordinate and prepare aggregate reports
Serve as aggregate report owner with overall responsibility for completeness and consistency in conjunction with PV Physician

Qualifications
RN, NP or PharmD degree with clinical experience _MUST HAVE THIS EXPERIENCE
Minimum of 2 years of pharmaceutical/biotechnology industry experience in PV including both clinical trial and post-marketing experience
Strong working knowledge of US/EU/AP/LA regulations and ICH guidelines
Working knowledge of MedDRA coding
Understanding of pharmacovigilance -related information systems
Experience with the preparation and submission of regulatory reports
Experience working in electronic document management systems