Main Responsibilities

• Provide scientific review and interpretation of safety data for the preparation of aggregate reports
• Conduct signal detection activities, signal evaluation and risk assessment, and manage the process for the development and management of Risk Management Plans
• Work cross-functionally to ensure that Clinical, Franchise, Asset Team and Regulatory objectives are met by reports being submitted according to international regulatory requirements and Company objectives and timelines. Interacts collaboratively and effectively in a team environment
• Understands, interprets, analyses, and clearly presents scientific and medical data in verbal and written format
• Provide scientific expertise to the preparation of responses to internal and external questions relating to the safety of allocated products; this includes the management and monitoring of external vendors used to author such documents
• Deliver efficient and timely review of clinical trial documentation
• Provide requisite regular reports of safety data, including appropriate scientific data analysis, to support the MDD and the GPS TAL/Physician in efficient medical monitoring
• Review clinical trials safety data throughout the clinical development programme to ensure that any medical issues are raised with the GPS TAL/Physician, 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 Patent Safety databases are accurately reconciled in a timely manner for all clinical trials
• Liaise with the GPS CRO staff to ensure that they understand their responsibilities for processing data as described in the 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
• Collaborate closely with manufacturing and Quality Safety Evaluation Board (QSEB)
• Provide GPS input and collaborate cross-functionally on medical devices and digital media if applicable to allocated products
• Provide GPS input and collaborate cross-functionally on Patient Data Collection Systems (like Patient
• Lead a team of safety physician and safety scientists for assigned products acting as Safety Asset Lead (if required)

Qualifications

• Bioscience graduate (BSc, BA, PharmD) or Master degree, PhD
• Extensive pharmacovigilance experience within pharmaceutical industry
• Working knowledge of pharmacovigilance legislations worldwide
• Prior experience with NDA/BLA or equivalent regulatory submissions, or experience working in a Regulatory Agency reviewing submission file
• Industry experience in clinical development
• Knowledge of product development processes
• Fluent in English

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