Associate Safety Director
Location - Welwyn Garden City
Duration- 18 Months
Offered rate - £80/hr - £100/hr Outside IR35
- 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 including, but not limited to STAR maintenance, ISMP maintenance. 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, labeling 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.
- Author or contribute to scientific publications (abstracts, posters, papers) for scientific meetings/journals
- Acts independently to manage safety responsibilities on study teams and in activities supporting safety science
- Take on the responsibility for specialized roles with PCS. These may include, but are not limited to; functional business process owner, subject matter expert.
Education, Skills and Experience
Qualified healthcare professional or Life Sciences graduate.
- A relevant postgraduate qualification (e.g. PHD/MSc in a Life sciences discipline; PharmD or other post-graduate health professional qualifications) would be advantageous.
Principal Scientist (lvl 3): 4 or more years of drug development experience in the pharmaceutical or related industry including at least 2 years in drug safety or a closely related field.
For further details, please contact Rudo Urayayi on +44(0)1727 817 616 or email a copy of your CV to email@example.com
- Agency: Achieva Group Limited
- Reference: RU-49-1
Website: Achieva Group Limited
- Posted: 8th March 2023
- Expires: 5th April 2023