Provided PV and risk management expertise to internal & external customers, safety expertise for assigned key strategic products, inputs for cross-functional Safety Management Teams, GPV internal Safety Analysis Teams
Lead MAA submission activities (FDA, EU, UK) for key strategic oncology products. Drafted support documentation as required to external partners, key opinion leaders, Health Authorities during internal and external negotiations
Supported due diligence activities and pharmacovigilance agreements for Oncology Biologics products
Provided support and insight for the preparation of clinical developments, protocols, IB, CSR reviews
Lead signal detection and analysis process methodologies and interpretation analysis of the results for products
Collaborated with Centre of Excellence for Risk Management and Safety Epidemiology
Lead benefit-risk assessment cross-functionally, prepared risk management strategies and plans and monitored effectiveness of risk minimization measures. Provided inputs to the safety management plan when required
Approved and validated reports: e.g., RMP, IND Annual Report, Annual Safety Report/DSURs/PSURs/PBRERs, etc.
Served as the medical safety expert to the GPV Periodic Reports group for assigned products.
Lead aggregate safety data review activities and coordinated safety surveillance activities