MSI Pharma are working with a globally recognised pharma company to help source a Senior Safety Scientist. The client is looking for someone with at least 5 years experience in safety signaling, aggregate report writing and risk management activities.
- Develop and maintain an understanding of the safety profile of their assigned
product(s) or therapy areas. Develop and maintain an expert understanding of the
safety profile of the assigned product(s) as well as understanding of the relevant
strategic context (e.g., disease under study, safety profile of competitors, mechanism of
action) - Responsible for individual and aggregate case reporting activities including ICSR
case management (medical review) and aggregate reporting (i.e. DSUR, PBRER) - Responsible for signal detection and management activities. Contribute to the strategy and review of safety assessments and drug safety reports for signals or issues (inc, product quality) or in response to Regulatory Authority requests
- Contribute to the development of the product safety strategy and provide drug safety
input into the Clinical Development strategy - Contributing to risk management activities including preparation and maintenance of
CCDS, labelling document maintenance (including the IB), risk communications, RMP,
REMS - Contributing to study management from a safety perspective through SMT/PET
activities and document review and maintenance across the development continuum
(early phase to post marketing studies), including PASS - Contribute to regulatory authority submissions (Investigational New Drug/IND
applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs,
Variations, Renewals, etc.) by reviewing safety data and preparing relevant sections of
the filing and submission packages in consultation with SPL - Responsible for the preparation and maintenance of safety sections of the Company
Core Data Sheet and/or Reference Safety Information in the IB - Participate in and provide input for Drug Monitoring Committees (iDMC) or internal
monitoring committee (IMC) meetings, as applicable - In partnership with the SSL, support presentation of important safety issues to the
Drug Safety Committee (DSC), Development Review Committee (DRC) and other
internal and external review and governance committees as needed. - Acts independently to manage safety responsibilities on study teams and in activities
supporting safety science
