Business Analyst for Clinical Safety and operations (Need locals)

Job Summary: We are seeking a highly skilled and motivated Business Requirements
Analyst to join our Business solutions team working in projects related to Clinical Safety
Management, Adverse Event analysis, Benefit-Risk analysis and Regulated Aggregate
reporting. The ideal candidate will play a pivotal role in gathering, analyzing, and
documenting business requirements for application development projects focused on
drug safety management and signal evaluation. This position requires specialized
knowledge of pharmacovigilance processes and regulatory standards to ensure the
successful delivery of innovative and compliant solutions.

Key Responsibilities:
Collaborate with cross-functional teams, including IT, clinical safety, and
regulatory, to elicit and document business and system requirements.
Analyze and model processes related to drug safety management, including
adverse event reporting, risk evaluation, and signal evaluation and signal
detection.
Translate complex business needs into detailed functional specifications for
application development teams.
Ensure alignment of requirements with regulatory standards such as FDA, EMA,
and ICH guidelines.
Conduct gap analyses and propose innovative solutions to improve efficiency
and compliance in drug safety processes.
Facilitate stakeholder workshops and requirement review sessions as per the
standard business analysis methodology.
Support the design and testing of applications to ensure they meet business
objectives and user needs.
Monitor and assess industry trends to identify opportunities for process and
system enhancements.

Preferred Skills:
Certifications such as CBAP (Certified Business Analysis Professional) or a
pharmacovigilance-related qualification.
Hands-on experience with safety systems like Argus or ArisGlobal is a plus.
Knowledge of data visualization tools like Power BI or Tableau.