Pharmacovigilance Specialist at Princeton, NJ

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