Senior PV Physician (remote-based)

Hobson Prior are working with a global pharmaceutical company who are currently looking for a Senior PV Physician to join them on a contract basis where you will be required to work remotely. Our client's goal is to go beyond the limits of science and change lives through ground-breaking medicines.

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

Job Responsibilities:

• Responsible for the Clinical Safety strategy for assigned drug projects and products throughout all stages of development and/or when on the market, including implementation and communication of the strategy at the project team/governance level.
• Responsible for the continued safety assessment, evaluation and risk management of products or product groups in various stages of clinical development and/or the post-marketing setting.
• Responsible for continuous efficient evaluation of adverse event and all other safety information in order to predict and manage the safety profile of compounds in clinical development and marketed products through identifying the need for update to reference safety information and drive proactive implementation of risk management initiatives in accordance with global regulatory requirements.
• Responsible for consistent communication of safety topics across all regulatory safety documents, eg. Periodic Benefit Risk Evaluation Reports, Periodic Adverse Drug Experience Reports, and Development Safety Update Reports. for assigned product(s)/programs(s).
• Proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature and other information sources in order to predict / establish the safety profile of compounds in clinical development, including employing expert groups and methodologies such as Safety Knowledge Groups, Safety Science, Informatics expertise, modelling and simulation to manage the risk to patients.
• Works collaboratively with experts from across, as well as colleagues from all three Science Units as leader/member of a Safety and Strategy Management Team or as a member of other cross-functional project teams, thereby promoting high quality evaluation of safety data.
• Understands the role of the QPPV and contributes to the maintenance of the pharmacovigilance system and processes.
• Supports key contacts with opinion leaders, as needed.
• Provides medical input and review of periodic reports and renewal documentation submitted to regulatory agencies.
• Leads the patient safety contribution to global regulatory submissions for new products, formulations or indications.

Requirements:

• Medical degree (eg MD, MBBS).
• At least 2 years of clinical experience post-registration.
• High level of medical competence, with an ability to balance this with industry standards to achieve business goals.
• At least 5-7 years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery.
• A thorough knowledge of the pharmaceutical/ biopharmaceutical industry, especially clinical research and global regulatory requirements (eg BLA, NDA or MAA) and practices governing expedited and periodic safety reporting, signal generation, safety evaluation and risk management activities.

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.