Overview

Reference Number: JO-2105-468935
Senior Drug Safety Scientist
Rate: Negotiable
Job Type: Permanent
Location: Boston

Senior Drug Safety Scientist

Are you an experienced safety professional interested in helping to build a pharmacovigilance function for a pioneer in a largely unmet space? An exciting opportunity has arisen at a leading biotech company focused on novel therapies for rare diseases – predominantly focusing on life saving anti-fungal treatments.

The company in question are a small business that have been in operation for over 20 years. Their leading product candidate operates on a completely different mechanism than currently marketed anti-fungal agents and has potential to work against a broad range of resistant fungal mould infections. Experience within this area or other rare diseases will enhance your application significantly.

My client is currently expanding their operations and are looking to bring their PV operations inhouse. The Senior Drug Safety Scientist will be the first permanent hire in this area and will be expected to take responsibility for the provision of safety and risk management input in support an ongoing global clinical development programme with chance to be at the forefront of safety for this company.

Remote working is available for this role however occasional domestic business travel may be required. The company are open to candidates based in the UK as well as on the east coast of the US.

Responsibilities:

  • Providing programme wide risk management support, revising SOPs and procedural documents.
  • Preparing signal detection reports/presentations in preparation for safety surveillance meetings including external safety experts/KOLs.
  • Providing support for both internal and external communication pathways
  • Supporting signal management
  • Preparing and reviewing regulatory submission documents and materials such as case study reports, investigator brochures, risk management plans, study protocols and interacting with global health authorities.
  • Providing support for all compliance mandates and regulatory requirements.
  • Supporting inspections and following up with any necessary actions.
  • Obtaining data extracts or other support safety deliberations by working closely with the pharmacovigilance vendor.
  • Additional duties as required.

Requirements:

  • Significant industry experience in safety science, pharmacovigilance or risk management.
  • Highly experienced in supporting regulatory filings (NDA, MAA etc.)
  • Knowledge of biostatistical methods used in pharmacovigilance surveillance, analysis and reporting.
  • Knowledge of ICH, US, UK and EU safety regulations.
  • Therapeutic knowledge in anti-fungal therapeutics or rare diseases preferred.

If this opportunity interests you and you would like to discuss this role in more detail please email your CV to sam.gibbons@cpl.com to set up a call and discuss further.

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