Associate Director (Safety Science)
Hobson Prior are recruiting for an Associate Director (Safety Science) to join a multinational healthcare company at their offices in Hertfordshire. This position will provide safety science and pharmacovigilance support to molecules across the organisation's portfolio.
- You will be responsible to develop and maintain an understanding of the safety profile of their assigned products 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).
- Accountable for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER).
- Accountable 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 or interna monitoring committee meetings, as applicable
- In co-operation 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.
- Strong presentation skills, effective at summarizing and presenting the key considerations and decision points.
- Strong orientation towards process improvement and cross-functional teamwork.
- Effectively work with remote partners on a global team.
- Excellent communication skills, both written and verbal.
- Ability to effectively train others on departmental practices and processes.
- 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.
- Apply complex data analysis / statistical methods to evaluate, interpret and present scientific data with clarity.
- Application of project management methodology.
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.
€650 - €700 per day
Hobson Prior are currently working with a global pharmaceutical organisation who are driven to help improve and prolong life.