Associate Director (Safety Science)

Hobson Prior are looking for an Associate Director (Safety Science) to join a multinational healthcare company on a contract basis in Hertfordshire. Our client focuses on researching and developing novel medicines and marketing them once they have been developed. As the Associate Director you will provide safety science and pharmacovigilance support to molecules across the organisation's portfolio.

Job Responsibilities:

• Responsible to develop and maintain an understanding of the safety profile of their assigned products or therapy areas.
• Accountable for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER).
• Develop and maintain an expert understanding of the safety profile of the assigned products as well as understanding of the relevant strategic context.
• 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.
• Applications/MAAs, Variations, Renewals, etc.) by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with SPL.
• 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.

Key Skills:

• 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
• Apply complex data analysis / statistical methods to evaluate, interpret and present scientific data with clarity.

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.

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.