01Responsibilities
- Contributes to the development & maintenance of product safety profile. - Involved in all safety surveillance activities, which may include monitoring adverse events and all other safety information to manage the safety profile of the company products - Monitors the signal management process (i.E. set up process for periodic signal detection for company products, signal tracking, review meetings, signal detection overview reports, eRMR reports, etc) for the company product (s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities. - Collaborates with external provider representatives in the preparation and review of aggregate reports having thorough oversight over scheduling, tracking, compliance and quality with a focus on critical aspects like the summary of safety concerns, benefit-risk evaluation, conclusion, etc - Responsible for the monitoring and review of the Risk Management Plans (RMP)/Risk Evaluation and Mitigation Strategy (REMS) providing expertise to the content of the safety specification, risk management plan, risk minimization measures including the locally implemented risk minimization measures, and drives the implementation of risk minimization activities in accordance with global regulatory requirements. - Provides input in ensuring that risk minimization strategies are implemented appropriately in relevant documents such as product reference safety information - Provides inputs to deliver accurate safety evaluation documents with clear conclusions in response to internal, partner, or regulatory authority requests for safety data in collaboration with service providers and cross-functional teams - Discuss results of data evaluation with the pharmacovigilance safety review team, drug safety committee, and/or other key stakeholders - Provides inputs to the safety sections of CCDS, local labels, health hazard analysis, QA trend analysis, device hazard lists etc - Leads the initiatives for process improvement and ensures consistency regarding aggregate reporting, signal management, risk management plan preparation, and responding to ad-hoc safety questions. - Have knowledge of case processing, expedited reporting, and safety database concepts with thorough medical oversight over the external vendors on the medical review of ICSRs - Understands the role of QPPV and contributes to the maintenance of the pharmacovigilance system and process - Provides inputs to various pharmacovigilance documents like PSMF, SDEA, etc - Provides input and review for key regulatory or clinical documents (i.E. SMP, protocol, IB, SAE/SUSAR, safety sections of DSUR, ASR, CSR, integrated summaries of safety, etc.) related to pharmacovigilance - Collaborates with, medical monitors and other functional groups in the identification, analysis, and reporting of possible safety-related trends or concerns. - Responsible for the evaluation of safety data from pre-clinical studies, clinical studies, literature, and other sources to establish the safety profile of company products to manage risk to the patients - Participates in internal pharmacovigilance committee meetings as well as joint safety meetings with partners. - Participates and supports pharmacovigilance audit/inspection preparation and CAPA management - Provides inputs in the preparation/revision of SOPs, working guidance, and ensuring pharmacovigilance compliance. - Ensures document management as per good documentation practices and SOPs. - Ensures compliance, reconciliation, and review of safety data exchange agreements between partners. - Meets .
