Major Responsibilities: 1. Compliance: • Maintenance of CAT (Case activity tracker), Medical Query Tracker for India (ROW if any), PADER tracker. 2. Quality & Compliance Governance: • Revision/Review of quality system-related Standard Operating Procedures (SOPs) and Work Instructions (WIs) to ensure that there are clear written procedures in place describing the pharmacovigilance system. • Participating in any internal audits or external inspections on CPL Global pharmacovigilance functions. • Management of ad-hoc work/responsibilities as allocated by Head of Pharmacovigilance or designee. 3. PADER report management: • Make yearly Schedule for PADER • Data request for the PADER drafting on monthly basis according to DLP date and submission date. 4. MICC management: • Make incoming and outgoing call data and related procedure for handling the inquiries/queries and distribute it in different nature of the query/inquiry with communication to related department as required.. • Management of ad-hoc work/responsibilities as allocated by Head of Pharmacovigilance or designee. Skills and Competencies: 1. Pharmacovigilance Operations Knowledge 2. Case Processing & Data Management Expertise 3. Global Regulatory Reporting Compliance 4. Safety Database & Systems Proficiency 5. Workflow Coordination & Timeline Management 6. Quality Control & Documentation Accuracy
