Senior Business Analyst

2 weeks ago

South Plainfield, United States Katalyst Healthcares and Life Sciences Full time
Senior Business Analyst - Global Patient Safety - Pharmacovigilance
Department: Pharmacovigilance
Job Summary: As a Senior Business Analyst within the Pharmacovigilance group at our client you will play a key role in ensuring the effectiveness and efficiency of our drug safety operations. You will be responsible for analyzing and improving business processes, implementing technology solutions, and ensuring that our pharmacovigilance activities align with regulatory requirements and industry best practices. The ideal candidate will have a strong background in drug safety and pharmacovigilance, combined with excellent business analysis skills.
Key Responsibilities:
  1. Business Analysis and Process Improvement:
    • Analyze current pharmacovigilance processes and systems to identify areas for improvement.
    • Develop and implement strategies to enhance efficiency, data quality, and compliance in drug safety reporting.
    • Liaise between the pharmacovigilance team, IT department, and external stakeholders to ensure effective communication and project success.
  2. Technology Implementation and Management:
    • Lead the implementation of new pharmacovigilance software and tools.
    • Oversee the customization and optimization of existing systems to better meet pharmacovigilance needs.
    • Ensure technology solutions are compliant with regulatory standards such as EMA, FDA, and ICH guidelines.
  3. Data Analysis and Reporting:
    • Analyze safety data to identify trends, patterns, and potential risks.
    • Prepare and present reports to senior management, regulatory authorities, and key stakeholders.
    • Support the creation of risk management plans and safety update reports.
  4. Regulatory Compliance and Documentation:
    • Stay abreast of regulatory changes and updates in pharmacovigilance.
    • Ensure that all pharmacovigilance activities and documentation comply with regulatory requirements.
    • Assist in preparing for audits and inspections.
  5. Stakeholder Collaboration:
    • Collaborate with cross-functional teams including clinical research, regulatory affairs, and quality assurance.
    • Provide training and guidance to team members on pharmacovigilance processes and systems.
  6. Project Management:
    • Manage and oversee pharmacovigilance-related projects from inception to completion.
    • Develop project plans, timelines, and budgets, ensuring timely and cost-effective delivery.
Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Life Sciences, or related field.
  • Minimum of 8 years of experience as a Business Analyst ideally in pharmacovigilance and drug safety within the pharmaceutical industry.
  • Strong understanding of pharmacovigilance regulations and reporting requirements.
  • Proven experience in business analysis, process improvement, and project management.
  • Excellent analytical, organizational, and communication skills.
  • Proficient in pharmacovigilance databases and software.
  • Ability to work collaboratively in a team environment and manage multiple priorities.
  • Experience with data analytics and reporting tools.
  • Knowledge of risk management and quality assurance in pharmacovigilance.
Preferred Qualifications:
  • Certification in Business Analysis (e.g., CBAP, PMI-PBA).

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