Regulatory compliance associates® inc(rca) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challengesWe understand the complexities of running a life science business and possess areas of expertise that include every facet of r&d, operations, regulatory affairs, quality, and manufacturing.
Rca is currently recruiting for an pharmaceutical clinical trial & study safety sme for an audit for a pharmaceutical clientThis will perform the 2 day audit remotely with an additional 3- 5 day pre and post audit work.
Job description:
The safety sme will be working with other team members (auditors & sme’s) to conduct safety based work on a number of clinical trials and clinical studiesFor the work, they will be working on various studies and trials for drug candidates, conducting activities including (but not limited to):
Reviewing safety events
Analyzing safety data / analysis of raw data
Pv data agreements review
General clinical trial/study safety subject matter expertise
Support with safety narratives
Requirements:
Sop drafting
Ema regulations
Fda regulations (cfr’s)
Previous experience working on government projects in pharma sector (on top of private industry / big pharma)Full understanding of how to create sop’s
Qa/qc in a clinical trial setting
Gcp
Safety sop’s
Safety management plan review/input
M.dNot required but need to have medical experience/knowledge, i.eRn etc.
Diversity and inclusion programs at regulatory compliance associations® (rca) are strategically designed to attract, develop, and retain the industry’s most skilled and professionally talented individuals regardless of their race, sexual orientation, religion, age, gender, or disability status.
