Deputy General Manager - Pharmacovigilance Operations and Delivery Lead

Pharmacovigilance Expertise (End-to-end):

• Post-marketing Safety – End-to-end Icsr Processing

• Manage Cases From Diverse Post-marketing Sources Including Spontaneous Reports, Literature, Legal, Social Media, Patient Registries, Poison Control Centers, Patient Support Programs (Psp), Patient Assistance Programs (Pap), Post-marketing Surveillance Studies (Pmss/pass), Market Research Programs (Mrp), Product Quality Complaints, Medical Information Call Centers (Micc) And Health Authority Downloads.

• Oversee Follow-up Query Management Ensuring Compliance With Global Regulatory Timelines.

• Post-marketing Safety – End-to-end Icsr Processing For Clinical Trials

• Handle Cases From Interventional Clinical Trials (Company-sponsored And Non-company Sponsored), Compassionate Use Programs (Cup), Susar (Including Comparator And Smpc Susars), And Sae Reconciliation.

• Perform Unblinding, Manage Follow-up Queries, And Support Protocol Configuration Updates And Change Controls.

Aggregate Reporting, Risk Management & Signal Detection & Management:

• Support And Collaborate With Aggregate Reporting Teams In Preparation And Submission Of Dsur, Pbrer, Psur, And Pader.
• Support Development, Implementation, And Lifecycle Management Of Rmp, And Conduct Rems Monitoring.
• Implement Rmp-focused Follow-up Processes And Additional Risk Minimization Measures (Armms).
• Supported Signal Validation, Prioritization, Evaluation.

Global Submissions And Distribution:

• Submit And Distribute Safety Cases To Global Health Authorities Including Ema, Fda, Tga, Nmpa (China), Mfds (Korea), And Health Canada.
• Manage Susar Notifications And Distribution To Internal And External Stakeholders.

Pharmacovigilance Agreements (Pvas) And Safety Governance:

• Oversee And Execute Pvas, Clinical Supply Agreements (Csas), And Sae Management Plans.
• Ensure Robust Safety Governance Frameworks And Partner Oversight.

Regulatory Intelligence:

• Monitor, Interpret, And Implement Updates From Global Pharmacovigilance Regulations.
• Translate Evolving Regulations Into Updated Processes And Sops.

Training, Compliance And Quality:

• Apply Expertise In Good Pharmacovigilance Practices (Gvp) And Good Clinical Practice (Gcp).
• Manage Deviations, Perform Root Cause Analysis (Rca), And Oversee Corrective And Preventive Actions (Capa) Including Closure.
• Maintain Inspection Readiness And Manage The Lifecycle Of Standard Operating Procedures (Sops).
• Lead Mock Inspections, Front-room/back-room Roles, And Inspection Readiness Plans.
• Train Pv Teams On Gvp, Systems, Process Changes, And Inspection Learnings.

Safety Systems And Technology:

• Operate Safety Databases Such As Argus, Arisg, Lifesphere Multivigilance (Lsmv), And Navax.
• Manage Dataflow From Rave To Lsmv And Other System Integrations.
• Perform Database Configuration, Data Mapping, Legacy Data Cleaning, Validation, And Testing (Uat, Regression, Smoke).
• Support Use Of Ai/ml/nlp Tools For Literature Screening, Duplicate Detection, Or Case Intake Automation And Measuring Case Processing Efficiency.

Project And People Management:

• Drive Lean/six Sigma Initiatives For Process Optimization And Efficiency.
• Monitor Kpis And Ensure Sla Compliance.
• Build And Maintain Strong Client Relationships And Cross-functional Collaboration.
• Support Budgeting, Forecasting, Resource Allocation, Contract Negotiation, And Change Control Processes.
• Lead Communication And Change Management During Transitions, Escalations, And Strategic Shifts.

Software Proficiency:

• Basic Knowledge Of Ms Office Tools, Including Powerpoint And Excel, Facilitating Efficient Documentation And Presentation.