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Physician (Global Patient Safety)
The role will support the Global Patient Safety Therapeutic Area Leaders with scientific analysis, data reviews, signal management and risk assessment activities, evaluation of product quality issues and emerging safety issues, including contribution to safety documents.
You will be required to:
Provide scientific review and interpretation of safety data for the preparation of aggregate reports such as Development Safety Reports (DSURs), Periodic Safety Update Reports (PSURs), etc; this includes the management and monitoring of vendors used to author such documents
Provide scientific expertise during signal detection activities, signal evaluation and risk assessment, and manage the process for the development and management of risk
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 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).
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 pharmacoviglance 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 trials
Liaise with GDD CRO staff to ensure that they understand their responsibilities for processing safety data as described in the RFP and contract, including contributions to safety data handling plans and other similar documentation, and that SAEs are reported to the Company according to the required timelines
Ensure the timely delivery of accurate information in DSURs, and SUSARs to investigators and Ethics Committees, with the generation of periodic line listings
Maintain awareness of changes to regulatory guidance documents, requirements and state-of-the-art pharmacovigilance processes, and make recommendations to improve effectiveness and maintain compliance
Regular review, update and implementation of pharmacovigilance business procedures documented in Standard Operating Procedures, guidelines and User Manuals
To contribute to the development of training courses for external and internal staff
Provide relevant subject matter expertise as required for audits and inspections, including any necessary pre-work in preparation for the audit/inspection, interviews with auditors/inspectors, as required, and follow-up on any subsequent actions and CAPAs
Experience & Qualifications:
Bioscience graduate (BSc, PharmD)
Fluent in written and spoken English Minimum
Awareness of pre- and post-marketing PV legislation
Proven scientific analytical skills Ideal
Previous experience of pharmacovigilance, either in industry or in a health authority
Knowledge of product development processes and experience of cross-functional team work
Sound knowledge of pharmacovigilance legislation
Prior experience with NDA/BLA or equivalent regulatory submissions, or experience working in a Regulatory Agency reviewing submission files
Experience of safety issues related to known target organ toxicities (e.g. hepatic, renal, haematological)
To all agencies: please no phone calls or emails to any employee of Ipsen in relation to this opening. All resumes submitted by search firms/employment agencies to any employee at Ipsen via email or any form of communication/method will be deemed the sole property of Ipsen, unless such search firms/employment agencies were engaged by Ipsen for this position and a valid agreement with Ipsen is in place. In the event a candidate who was submitted outside of the Ipsen agency engagement process is hired, no fee or payment of any kind will be paid.