Description
Responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.
Support Medical Safety Assessment Physicians (MSAP) in leading Safety Data Review (SDR) Teams.
Appropriately perform core signal detection activities and elevate program or portfolio issues impacting key MST programs, priorities, resources, and milestones with appropriate oversight.
Author responses for safety data queries and contribute to specified PV sections of the Periodic Perk Risk Evaluation Report (PBRER) and Development Safety Update Report (DSUR).
Ensure pharmacovigilance regulatory compliance with oversight
Lead Safety Data Review (SDR) Teams and participate in related PV and product-development subteam(s).
Appropriately elevate signal detection findings impacting key MST activities, milestones,
and documents to the MST Chair.
Support individuals in aspects of project management, drug development and MST requirements, as appropriate to meet overall MST/subteam needs.
Author and contribute to specified PV sections of the PBRERs and DSURs with oversight
Author responses to safety data queries from health authorities including coordination and integration of scientific, medical, and regulatory input from a variety of scientific sources and functional groups, to support responses to safety data/ad hoc queries and HA requests.
Perform periodic review and summary of pertinent safety related literature and analysis of pre-determined core signal data.
Collaborate within and across company functions with appropriate disciplines to identify and ensure management of internal and external documentation and support when required.
Share with individuals and teams on these applied learning's.