Drug Safety Analyst

Duration & Type: 12 months Contract with a major pharmaceutical industry client

Location: Los Angeles, California

Responsibilities:

• Provide operational support for global pharmacovigilance activities for investigational and marketed products.
• Ensure pharmacovigilance deliverables are of the highest quality and meet global regulatory reporting timelines.
• Responsible for data analysis and management obtained from the integrated database utilized by worldwide pharmacovigilance personnel.
• Responsible for project implementation and execution of the system, including responsibilities for providing ongoing safety business support and ongoing improvements.
• Key interface with IT system administrators to verify and test system changes, ensuring the system is compliant and meets business needs.
• The personnel who cover the workplace will develop their activities according to the Pharmacovigilance System Master File (PSMF), Standard Operating Procedures (SOPs) and Working Practices (WPs) and following the Pharmacovigilance legislation

Required:

• Education: A university degree in health sciences/ biosciences and additional training in IT or have a university degree in IT with additional training and/or experience in pharmacovigilance
• At least 2 years of relevant experience in pharmacovigilance and 2 years of relevant experience in managing data bases, is required.
• Knowledge of pharmacovigilance practices; existing legislation, regulations and guidelines; medical coding and safety-data administration.
• Availability for international travelling when necessary is also required.
• Proven Self-starter with strong work ethic and the ability to exercise good judgment.
• Must possess strong technical writing and communication skills with ability to create and present design proposals, test scripts, execute training sessions and conduct effective meetings.
• Familiarity with validation of computer systems and/or GMP environments is essential.
• Knowledge of E2b (R2) and E2b (R3) is beneficial.
• Familiarity with Medical terminology, MedDRA, WhoDrug is beneficial
• Familiarity with reporting tools such as Business Objects is strongly preferred.

For consideration, please send resume to career@infoquestgroup.com