Global Senior Director - Drug Safety Lead – Oncology / Immunology
You will be responsible for leading Global Safety Team which are responsible for ensuring the safety of patients treated with the Company's products. The Senior Director will play a key role in the identification and execution of safety strategies to ensure successful development, and progression to market approval, for new drug entities in North America and the EU, whilst considering the needs of Japan and Asia.
- Leading Global Safety Team(s) to develop safety strategies for the meeting of Company targets and ensuring patient safety and regulatory compliance including for products that are in development and / or marketing.
- Providing medical analyses and input to meet international regulatory requirements and Company's objectives.
- Supporting in increasing the department's effectiveness and profile within the company and wider group.
- Supporting the Qualified Person for Pharmacovigilance in Europe by contributing to the constant improvement of the company's Pharmacovigilance System.
- Determine the safety strategy for the preparation of regulatory submissions for new Marketing Authorisation Approvals in EAA and USA and ensure the delivery of high quality safety documentation for those submissions.
- Lead the preparation of Benefit Risk Assessments for company products and provide appropriate support for implementation of the associated conclusions.
- Developing proactive risk management strategies for marketed and / or investigational compounds ensuring that these are contained and implemented in appropriate strategies including Risk Management Plans. Ensure success of such activities by close liaison with Submission teams.
- Lead signal detection activities using data from all sources and bring medical expertise to drive Benefit Risk assessment reports, support of Company Core Data Sheets and other similar reports and actions.
- Provide medical review and interpretation of safety data for preparation of aggregate reports and ensure consistent messaging across all such reports and documents issued for both development and post marketing purposes.
- Contribute to the preparation and review of Pharmacovigilance documentation for internal and external use by providing medical expertise to the preparation of responses to internal and external questions relating to the safe use of company products, safety issue works up etc.
- Ensure that updated safety profiles of company products are provided to senior management as required.
- Represent Pharmacovigilance at internal and external meetings where issues of drug safety are to be, or may be, discussed.
- Maintain awareness of changes to regulatory guidance documents, requirements and state-or-the-art Pharmacovigilance processes and make recommendations leading to the improvement of the effectiveness and profile of the department.
- Participate, when requested, in due diligence ensuring clear recommendations for progression to agreement
- Ensure that Ethics and Medical Compliance is applied within all Pharmacovigilance activities
- To work cross functionally within project teams to meet Company objectives and to represent the Department of Pharmacovigilance in a team-oriented manner and delivering quality and timely input to meet the needs of the project team
- Any other activity that may reasonably be required.
Please direct all questions (if necessary) to “Chris” at email@example.com cswain (at) barringtonjames (dot) com alongside a copy of your CV.
- Posted by Chris Swain Team Sales Manager