Safety Signal Detection
Job Title :Senior Consultant – Safety Signal Detection
Location:Preferably Foster City / Freemont, CA. Remote option available
Duration:6 months / Contract to Hire
Qualifications Required:Bachelor’s degree in Computer Science or Engineering and/or equivalent experience/training
Job Description :
- 8+/extensive technical and functional knowledge of Global Pharmacovigilance IT Systems like Argus Safety, Argus-J, AEGIS (Adverse Event Gathering and Integration System), AIR (Argus Internal Reports), HDR (Healthcare Data Repository) and ESS (Empirica Trace) and other commercially available drug safety system.
- Experience in the implementation of signal detection functionality to pharmaceutical /biotechnology companies / regulatory agencies in the areas of clinical development and post-marketing.
- Hands on experience with IT system assessment and comparative analysis, business data modelling and business process modelling.
- Ability to perform IT System Assessment, Regulatory Assessment, Personal and Security Assessment, conduct impact analysis and author assessment report/recommendation roadmap.
- Extensive experience in complete SDLC implementation of many large and medium-sized projects.
- Ability to understand large complex processes with a focus on improvement and awareness of emerging trends.
- Apply enthusiasm and interest in all computer related activities.
- Must be able to lead requirement workshops, design, prototype, configure and document effective solution.
- Must have strong presentation, technical writing skills, analytical skills
- Strong networking skills and being proactive with the ability to work independently as well as have ability/willingness to work in a global environment with product vendors and other partners.
Good to have / desirable experience:
- Direct experience in ‘time-boxed’ strategic consulting engagements
- Direct experience with performing a medical assessment of individual case safety reports (ICSRs) to determine seriousness, expectedness, and causality of adverse events.
- Direct experience with performing signal detection and analysis activities e.g. managing and tracking signals, identify potential signals, validate and perform the signal assessment.
- Experience in data mining methods for detection and evaluation of safety signals.
- Experience in authoring safety aggregate reports like PSUR, DSUR, Risk Evaluation, and Management Strategy(REMS).