Global Patient Safety Physician

Hobson Prior is seeking a Global Patient Safety Physician for a leading biotechnology company to be based in Slough on a permanent basis. You will be accountable for providing scientific review and interpretation of safety data for the preparation of aggregate reports such as Development Safety Reports, Periodic Safety Update Reports, etc.

Job Responsibilities:

• Deliver scientific expertise during signal detection activities, signal evaluation and risk assessment, and manage the process for the development and management of Risk Management Plans.
• Provide scientific expertise to the preparation of responses to internal and external questions relating to the safety of products on the market or during clinical trials; this includes the management and monitoring of external vendors used to author such documents.
• Deliver efficient and timely review of clinical trial documentation (protocols, study reports, monthly reports of serious adverse events, etc).
• Work cross-functionally to ensure that Clinical, Franchise and Regulatory objectives are met by reports being submitted according to international regulatory requirements and Company objectives and timelines.
• Provide requisite regular reports of safety data, including appropriate scientific data analysis, to support the MDD and the GPS TA Leader in efficient medical monitoring.
• Assist in the implementation of Data Safety Monitoring Committees, ensuring the provision of accurate high-quality pharmacovigilance data for review.
• Review clinical trials safety data throughout the clinical development programme, to ensure that any medical issues are raised with the GPS TA Leader, and that data meet the quality standards for regulatory requirements
• Provide, or ensure the provision of, an overview of pharmacovigilance definitions and Standard Operating Procedures to study investigators and site monitors at study set-up, and whenever necessary during the running of the trial, in order to ensure that serious adverse events (SAEs) are reported to the Company in a timely and accurate manner and that regulatory safety requirements are understood and met.
• Liaise with Global Drug Development CROs to ensure that SAE data within the clinical and Global Patient Safety databases are accurately reconciled in a timely manner for all clinical trials.

Key Skills:

• Able to deliver high quality accurate work, presenting complex data in an understandable way.
• Strong team player with excellent networking and influencing skills.
• Ability to prioritise own workload, work under pressure and achieve strict timeline targets.
• Excellent verbal and written communication skills.

Requirements:

• Bioscience graduate (BSc, PharmD).
• Fluent in written and spoken English.
• Awareness of pre- and post-marketing PV legislation.
• Proven scientific analytical skills.
• Previous experience of pharmacovigilance, either in industry or in a health authority would be admirable.
• Knowledge of product development processes and experience of cross-functional team work is ideal.

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.