Specific Responsibilities Include (but are not limited to):
- 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.
- 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
- 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