A new 12-month contract vacancy has opened for a Senior Safety Scientist to join a world-wide pharmaceutical organisation focused on the research and development of novel medicines and marketing them once they have been developed.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Responsible for coordination and collaboration with vendors servicing Safety Science.
• Adopt the responsibility for appropriate specialised roles with PCS. These may include, but are not limited to; functional business process owner, subject matter expert.
• Produce and maintain an understanding of the safety profile of their assigned product(s) or therapy areas.
• You will be responsible for working independently to manage safety responsibilities on study teams and in activities supporting safety science.
• Contribute to input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable.
• 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.
• Contributing to risk management activities including preparation and maintenance of CCDS, labeling document maintenance, risk communications, RMP, REMS.
• Contributing to study management from a safety perspective through SMT/PET 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 SSL and PCS Team Lead.

Key Skills:

• You will have strong communication skills, both written and verbal.
• Excellent presentation skills, while being effective at summarising and presenting the key considerations and decision points.
• Effectively work with remote partners on a global team.
• Strong orientation towards process improvement and universal teamwork.

Requirements:

• You will be a qualified healthcare professional or Life Sciences graduate.
• A relevant postgraduate qualification (e.g. PHD/MSc in a Life sciences discipline; Medical qualification; PharmD or other post-graduate health professional qualifications) would be advantageous is preferable.
• Understanding of GxP and regulated processes and end to end clinical trial lifecycle.
• The ability to perform data analysis / statistical methods to evaluate, interpret and present scientific data with clarity.
• Ability to train others on departmental practices and processes .
• Understanding of project management methodology.
• (For roles in China) Fluent in Mandarin and English.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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.