Clinical Trial & Pharmacovigilance Manager
Location: Hybrid
Job Type: Full-Time
Venesco is seeking an experienced Clinical Trial & Pharmacovigilance Manager to oversee clinical trial operations and ensure robust safety surveillance practices.
Requirements
Key Responsibilities: • Manage clinical trial operations from startup through closeout • Oversee adverse event reporting and pharmacovigilance systems • Ensure compliance with ICH-GCP and regulatory requirements • Coordinate DSMB activities and safety reviews • Develop and maintain clinical study documentation • Collaborate with regulatory teams on submissions
Minimum Qualifications: • Advanced degree in clinical research, life sciences, or related healthcare field • 8+ years of clinical operations and safety experience • Strong knowledge of ICH-GCP and FDA regulations
Preferred Qualifications: • Experience with Argus or ArisG safety databases • Clinical trial management certification
We have evolved over the past 18 years, starting as a small consulting business and emerging as a well-respected business specializing in biomedical R&D and IT support services.
Our success on federal initiatives is the product of our distinguished professional employees, agile management & quality processes, and financial aptitude. We have solid financials and mature processes, backed by our recognition in Inc. 5000 and Washington Technology's Fast 50 in 2017, 2018, 2019, 2020, and 2021. We possess a Top-Secret Facility Clearance and hold certifications for CMMI® Maturity Level 3 (ML3) for services and ISO 9001:2015 and 14001:2015.
Our 14 prime multiple-award IDIQ contracts have yielded a wealth of expertise in program, task order, and contract management worldwide. Venesco runs 65+prime contracts, ranging in size from as few as one or two employees to programs with 150+ employees. With over 350 credentialed employees, Venesco is a nimble small business with a large business impact and reach.
