Beacon Hill Life Sciences is seeking an Intern in Pharmacovigilance Systems in Newton, MA. This is a potential 6 month contract to hire opportunity.
Job Duties :
Maintain database configuration and corresponding documentation including study, product and table maintenance.
Ongoing evolution of interactive database systems and processes. Testing and documenting potential solutions for automating portions of the overall system.
Standard Operating Procedures (SOP) writing and impact analysis. Understanding of the impact of change and how to measure the effectiveness while creating and maintaining documentation to support the Pharmacovigilance Department.
Change control planning, testing and implementation.
Design and build reports that comply with all regulatory standards to meet the needs of the Pharmacovigilance Department.
Maintains knowledge of adverse event reporting process and the safety system and contribute to the development, improvement and standardization of new processes and methods.
Experience and Background :
S. or late stage of B.S. degree program, or the equivalent combination of relevant education.
Experience with knowledge of Pharmacovigilance regulations and Regulatory affairs or a related field of study is preferable but not required.
Working knowledge of relational databases and business intelligence tools.
Understanding of relevant US, EMA and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments is preferable.
Excellent communication skills, both written and verbal.
Strong computer skills. Full Microsoft Office Suite, a programming language, SQL.
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
Company Profile :
Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.
Our niche brands provide direct hire, executive search, temporary staffing, contract consulting and temp / contract-to-hire solutions to emerging growth companies and the Fortune 500 across market sectors, career specialties / disciplines and industries.
Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.