Drug Safety Analyst - Global Pharmacovigilance

Job Title: Drug Safety Analyst - Global Pharmacovigilance
Work Location: Chicago, IL (100% remote)
Tentative End Date: 12 months+

Work Shift (Days/Times): 1st shift

Pay Range: $51.74/hr. on W2

Manager’s Note:
We would like someone who can perform the duties at the Biostatistician base level without requiring an Epidemiologist or doctor.
 
Drug Safety Analyst, Global Pharmacovigilance
Join our dynamic Drug Safety & Risk Management team at Client 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.
• These 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.

 
Number of Leased Workers Needed: 1
Tentative Start Date: ASAP
Travel Required (% of Travel): No
Is This a Temp to Perm Position: Pure contract