Pharmaceutical Data Analyst Jobs

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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

Essential Functions:

• 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

Required Knowledge, Skills, and Abilities:

• 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)

Description of Physical Demands & Work Environment:

• Occasional mobility within office environment.

• Routinely sitting for extended periods of time.

• Constantly operating a computer, printer, telephone and other similar office machinery.

• Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations, and temperature changes.

• Frequent computer use at workstation.

• May move from one work location to another occasionally.

• Responsibilities may require a work schedule that may include working outside of “normal” work hours to meet business demands.

• Occasional public contact requiring appropriate business apparel.