About the Organization:
FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Their staff includes experts in health, education, nutrition, environment, economic development, civil society, gender, youth, research and technology — creating a unique mix of capabilities to address today's interrelated development challenges. FHI 360 serves more than 70 countries and all U.S. states and territories.
Coordinates safety management and pharmacovigilance activities for Phase 1-4 clinical trials.
- Develops, manages and oversees safety management vendor contracts for one or more clinical projects.
- Under guidance of senior research staff, develops and maintains key safety documents such as safety management plans and medical monitoring plans to ensure adequate resource and reference documentation.
- Serves as the liaison with internal and external partners, including sponsors and clinical study staff for serious adverse events (SAE) management tasks and reports.
- In collaboration with project team staff, participates in planning of meetings and drafting necessary documents related to safety.
- Manages SAEs for research projects sponsored by FHI 360 or external sponsors. Specifically:
- Manages and process SAE reports
- Under guidance of senior research staff, generates and coordinates submission of safety reports to regulatory authorities in coordination with regulatory team, external safety management vendors or study sponsors
- Coordinates SAE reconciliation
- Responsible for filing all safety-related documentation in eTMF
- Assists with MedDRA and WHO Drug coding tasks.
- Develops and maintains SOPs, work instructions and templates regarding safety management and pharmacovigilance.
- Ensures compliance with government regulations when writing and reviewing protocols, safety management plans and reports.
- Develops training materials and conducts training for study implementation based on company policies and standard operating procedures (SOPs).
- Provides input with questionnaire development, analysis, study design, and material management.
- Plans, organizes, and manages resources/processes for successful completion of study goals.
- Assists with the development of clinical sections of protocols and informed consents for research studies.
Applied Knowledge & Skills:
- Working knowledge of concepts, practices and procedures for conducting clinical research studies under ICH GCP guidelines and governmental regulations.
- Excellent oral and written communication skills.
- Ability to analyze and interpret medical research data, review clinical trial protocols, summarize safety data, identify errors and prepare reports.
- Strong attention to detail, project management and organizational skills.
Problem Solving & Impact:
- Works on problems of moderate scope that require analysis or interpretation of identifiable factors.
- Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
- Decisions may affect a work unit of area within a department.
- Receives methods and procedures on new studies.
- Provides suggestions on business and operational decisions that affect the department.
- Serves as pharmacovigilance lead to team members.
- Typically reports to a Manager.
- Master’s Degree or its International Equivalent • Knowledge/Information Services,
- Communications, Education, Environment, Health, Behavioral, Life/Social Sciences
- International Development, Human Development or Related Field.
- Typically requires 5-8 years of clinical research experience with study implementation.
- Proficiency in Microsoft Office, spreadsheets, analytical software and other technology required.
- Articulate, professional and able to communicate in a clear, positive fashion with clients and
- Must be able to read, write and speak fluent English.
- Related prior work experience, such as experience with pharmacovigilance and drug safety databases preferred.
Typical Physical Demands:
- Typical office environment. Ability to sit and stand for extended periods of time; ability to lift
- 5-50 lbs.
Technology to be Used:
- Personal Computer, Microsoft Office (i.e. Word, Excel, PowerPoint, Project etc.), e-mail, telephone,
- printer, calculator, copier, and cell phones.
Travel Requirements:: 5%