Drug Safety Physician

Hobson Prior are currently looking for a Drug Safety Physician to join a brilliant pharmaceutical establishment on a contract basis. Our client is focused on providing transformative remedies.

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

Key Responsibilities:

• For this role, you will guide the patient safety input to international regulatory proposals such as NDA, BLA, MAA for new products, formulations or indications.
• Offer knowledge to medical content on the safety specification, pharmacovigilance plan and risk minimisation actions in the core RMP, CPRL and internationally evaluated LRMPs.
• You will serve as a representative for PS on cross-functional clinical teams and/or project teams for developmental and/or marketed products.
• To guarantee that risk-minimisation tactics are executed suitably in pertinent papers such as product reference safety information, you will direct medical contributions.
• Offer tactical input into replies to regulatory requests for regional label aberrations from the organisation core safety documentation.
• The ideal candidate will set the method for regular signal management actions.
• Partake in and/or evaluate the PS component of Safety Agreements.
• Any other assigned duties.

Requirements:

• Educated to an advanced degree level in a medical discipline.
• At least 2 years of experience with clinical post-registration.
• Medical proficiency with the ability to balance it with organisation standards to accomplish business objectives.
• At least 5-7 years of experience with drug development/patient safety with proven experience of delivery.
• Knowledge of pharmaceutical and/or biopharmaceutical organisations.
• Know-how of clinical research and international regulatory needs such as BLA, NDA or MAA, as well as practices governing expedites and periodic safety documenting, signal production, safety review and risk management actions.

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.