Job Description
Responsibilities:
1. Aggregate Reporting & Compliance
• Review, translate, prepare, submit, and track local aggregate reports in accordance with regulatory requirements.
• Coordinate submission timelines with Global Medical Safety (GMS) and local Regulatory Affairs to maintain alignment with the Global Aggregate reporting schedule.
2. Local Regulatory Intelligence
• Monitor and evaluate changes in local PV regulations, performing impact assessments on global and local procedural documents.
• Implement new or updated PV regulations and provide input to enhance LMS-wide processes, systems, and policies.
• Engage in local industry associations to drive policy-shaping initiatives.
3. Pharmacovigilance Service Provision
• Oversee day-to-d...
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