Associate Director Safety Science

Hobson Prior are recruiting for a Associate Director Safety Science to join a multinational healthcare company located in Hertfordshire. This position will provide safety science and pharmacovigilance support to molecules across the organisation's portfolio.

Job Responsibilities:

• You will develop and uphold an expert understanding of the safety profile of the assigned products as well as understanding of the relevant strategic context.
• Accountable 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 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.
• Partake in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable.
• Working with the SSL, support presentation of important safety issues to the Drug Safety Committee, Development Review Committee 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.

Key Skills:

• Effectively work with remote partners on a global team.
• Excellent communication skills, both written and verbal.
• Apply complex data analysis / statistical methods to evaluate, interpret and present scientific data with clarity.
• Strong presentation skills, effective at summarizing and presenting the key considerations and decision points.
• Ability to effectively train others on departmental practices and processes.

Requirements:

• 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.
• Understanding of GxP and regulated processes and end to end clinical trial lifecycle.
• Application of project management methodology.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.