MARS Solutions Group is looking for an experienced Statistician III/ Drug Safety Analyst, Global Pharmacovigilance , for a client located in Chicago, IL, USA . Our client is a well-known Healthcare technology and organization seeking bright, tech-savvy talent.
Client Industry: Healthcare Industry
Location : Chicago, IL , USA
Job Type : 100% Remote
Job Title: Services - Statistician III/ Drug Safety Analyst, Global Pharmacovigilance
Experience Level : Degree in Statistics or Biostatistics: A bachelor's or master's degree in statistics, biostatistics, or a related field is essential Analytical Skills: Knowledge of various signal detection methods such as disproportionality analysis and Bayesian approaches. Ability to perform trend analysis and identify patterns in ADR data.
Nice to Have Skills : Regulatory Knowledge: Understanding of regulatory requirements and guidelines for drug safety reporting (e.g., FDA, EMA guidelines).
Schedule/Hours: First
Is this a temp to perm position Contract.
Essential Responsibilities:
"We would like someone who can perform the duties at the Biostatistician base level without requiring an Epidemiologist or doctor.".
Join our dynamic Drug Safety & Risk Management team at GE Healthcare, where we are dedicated to ensuring the safety of our products and the well-being of patients worldwide.
As a Drug Safety (DS) Analyst, you will support performing pharmacovigilance tasks and preparing regulatory and internal documents with precision and compliance. This tasks help ensure that potential safety issues are identified and addressed promptly, contributing to the overall safety and efficacy of pharmaceutical products. Your work will support product safety signal detection and product safety risk management.
Key Responsibilities:
Perform Adverse reaction trending: identifying patterns and trends in adverse drug reactions (ADRs) over time to detect any emerging safety signals.
Contribute to Signal Detection: Using statistical methods to detect signals of potential safety issues from spontaneous reporting databases.
Graphical Representation: Creating visual summaries such as line graphs or heat maps to illustrate trends in ADRs.
Safety Reports: Preparing detailed safety reports that include the analysis of ADR trends and frequencies for submission to regulatory authorities.
Risk-Benefit Analysis: Support risk-benefit analyses to assess the overall safety profile of a drug in light of the observed adverse events.
Required Qualifications:
Degree in Statistics or Biostatistics: A bachelor's or master's degree in statistics, biostatistics, or a related field is essential
Analytical Skills: Knowledge of various signal detection methods such as disproportionality analysis and Bayesian approaches. Ability to perform trend analysis and identify patterns in ADR data
Data Management: Skills in managing large datasets and using databases specific to pharmacovigilance.
Report Writing: Strong skills in writing clear and concise safety reports
Collaboration: Ability to work effectively with cross-functional teams, including clinical research, regulatory affairs, and medical affair.
Pharmacovigilance Training: Specialized training or certification in pharmacovigilance can be highly beneficia.
Regulatory Knowledge: Understanding of regulatory requirements and guidelines for drug safety reporting (e.g., FDA, EMA guidelines)
Desired Characteristics:
High level of accuracy, attention to detail, and quality in all tasks.
Independent and proactive, with a strong initiative.
Why Join Us:
Professional Growth: Opportunities for continuous learning and career advancement.
Impactful Work: Contribute to the safety and well-being of patients globally.
About MARS Solutions Group:
MARS Solutions Group is an IT staffing firm with access to a wide variety of jobs at various clients across the country. We operate with the consultant's best interests in mind and align them with roles that match their skills, aspirations, and interests. MARS values our relationships with consultants. Therefore, we will stay in touch throughout the duration of the contract to ensure the job is going well and that the role meets their career development needs.
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