Hobson Prior are looking for a Senior Safety Physician to join a worldwide pharmaceutical organisation on a 12-month contract where you will work remotely. You will be responsible for carrying out the clinical safety strategy for assigned drug projects and products for a worldwide pharmaceutical organisation who changes lives everyday by providing millions of people with medicines globally.

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

Key Responsibilities:

• You will be responsible for reviewing and endorsing the core Risk Management Plan (RMP)/Core Patient Risk Log (CPRL).
• Provides expertise to the medical content of the safety specification, pharmacovigilance plan and risk minimisation activities in the core RMP, CPRL and globally reviewed LRMPs.
• Represents PS on cross-functional Clinical Teams and/or Project Teams for developmental and/or marketed products.
• Leads medical input to ensuring that risk-minimisation strategies are implemented appropriately in relevant documents such as product reference safety information.
• Provides medical input to regulatory supporting documentation for labelling updates.
• Provides medical input into Identification and utilization of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals.
• 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 AZ 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 (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), and Development Safety Update Reports (DSURs). for assigned product(s)/programs(s).
• Supports key contacts with opinion leaders, as needed.
• Working with the Safety Team, you will be 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 safety strategy at the project team/governance level. Activities include, but are not limited to: definition of identified and potential risks, proposals for mitigation and minimisation measures, safety go-no-go criteria for the clinical programme, input to TPP/TPC, safety submission strategies, response to regulatory safety queries and definition of risk component of the benefit/risk assessment
• Sets the strategy for routine signal management activities.
• Provides medical input and review of periodic reports (eg PBRERs, PSURs, DSURs) and renewal documentation submitted to regulatory agencies.
• Leads the patient safety contribution to global regulatory submissions (NDA, BLA, MAA etc) for new products, formulations or indications.
• Any other assigned duties.

Requirements:

• The ideal candidate will require a medical degree (eg MD, MBBS).
• A minimum of 2 years of clinical experience post-registration.
• 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.
• High level of medical competence, with an ability to balance this with industry standards to achieve business goals.
• 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.