Data Analyst, Rems Strategy & Operations

Data Analyst, REMS Strategy & Operations

6 Month Contract (potential to extend / possibly convert)

Fully Remote

No C2C

MUST HAVE:

• Exp. in Drug Safety/Pharmacovigilance, ICSR processing
• Experience with ARGUS/ARISg), MedDRA and WHO drug dictionary
• REMS experience preferred
• Medical terminology and ability to summarize medical information
• Bachelor's Degree (health or biological science field)
• Experience in data collection, trending and reporting metrics

Data Analyst, REMS Strategy & Operations will support various aspects of company portfolio of Risk Evaluation and Mitigation Strategy (REMS) and Risk Management Programs, contribute to development and research for new and existing risk management programs. This role will contribute to cross-functional team deliverables and action items for REMS Strategy & Operations. Alignment between this role and other cross-functional areas will be critical to success and will require collaboration across multiple departments

RESPONSIBILITIES

• Support US REMS and ex-US Risk Management Program operational data and reporting requirements

• Support for active monitoring of products that require risk management programs

• Support in the development and data collection for annual REMS Assessment report

• Review/assess inbound REMS and ex-US Risk Management Program specific reports for longitudinal view of potential abuse, misuse, diversion, and non-compliance

• Categorize REMS and ex-US Risk Management Program required reports in the REMS Strategy & Operations dashboard

• Track and trend categories of REMS and ex-US Risk Management Program and vendor required reports

• Assist with reconciliation activities performed for US REMS and ex-US Risk Management Programs

• Support in data analysis, initiatives, report preparations, and other REMS Strategy & Operations cross-functional projects

• Ensure compliance with corporate and departmental standard operating procedures and completion of all assigned training on company procedural documents

EDUCATION / REQUIREMENTS

• Individual Case Safety Report (ICSR) processing experience is required

• Experience using or familiarity with ARGUS, ARISg or other safety database applications

• Experience using or familiarity with MedDRA and WHO drug dictionary

• Experience in data collection, trending and reporting out metrics

• Understanding of medical terminology and ability to summarize medical information

• Proficient in Microsoft tool suite (Word, Excel, PowerPoint, Outlook)

• Excellent oral and written communication skills

• Highly organized and demonstrates consistent attention to detail

• Self-sufficient/discipline for remote work environment when necessary

Required/Preferred Education and Licenses:

• Bachelor’s degree in a health related or biological science related field (health care degree preferred)

• 2-3 years of Drug Safety/Pharmacovigilance (REMS experience preferred)