Evaluates adverse drug reaction reports from multiple data sources globally. Performs benefit-risk assessment for drugs in the company's portfolio. Leads signal detection activities using statistical and qualitative methods. Prepares and reviews Risk Management Plans (RMPs) for regulatory submissions. Manages SUSAR reporting timelines and ensures compliance with global regulations. Supports preparation of PBRER, DSUR, and annual safety reports. Reviews protocols and informed consent forms for safety-related considerations. Maintains pharmacovigilance system master file (PSMF) documentation. Coordinates with global safety team and affiliates on safety communications. Manages safety data exchange agreements with partners and licensees. Conducts pharmacovigilance training for internal and external stakeholders. Supports regulatory authority queries on safety matters for marketed products. Stays current with EMA, FDA, CDSCO pharmacovigilance regulations and guidance.