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GlaxoSmithKline LLC Medical Director SERM in Collegeville, Pennsylvania

Reference #: 277628Site Name: USA - North Carolina - Research Triangle Park, USA - Pennsylvania - Upper ProvidencePosted Date: Jan 26 2021Are you a safety/pharmacovigilance physician with in-depth and hands-on experience?As the SERM Oncology Medical Director, you will provide high level medical expertise in the safety evaluation and risk management of new oncology medicines in clinical development and/or the post-marketing setting. You will ensure that adverse event and other safety information is efficiently evaluated in order to meet global compliance and regulatory requirements, identify the need for product labelling updates and drive proactive implementation of risk management initiatives.You will have a proven ability to lead safety evaluation activities, ensuring that appropriate safety objectives and risk minimisation strategies are included in clinical development programmes. You will influence at all levels of the organisation using your experience, confidence and credibility, and represent the disease area or product area safety strategy at key internal GSK meetings and externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners. Additionally, you will be accountable for medical review and sign-off for regulatory documents, including periodic safety update reports (PSURs).This role will span the work of project and product safety as practiced by physicians in both the GCSP SERM: Development and GCSP SERM: Mature Products groups. Global Clinical Safety and Pharmacovigilance (GCSP) is responsible for the collection, processing and regulatory reporting of adverse events experienced by patients receiving GSK products and for the ongoing safety evaluation and risk management of all GSK products (marketed or developmental).GSK considers the clinical safety of its products to be of paramount importance.Key ResponsibilitiesSafety Governance and Risk Management activitiesDrives pharmacovigilance and risk management planning in the clinical matrix and leads production of global Benefit-Risk Management Plans for designated productsLeads safety input into regulatory benefit-risk assessments, prepares the regional Risk Management Plans for designated products for submission to regulatory authoritiesDelivers the clinical safety input into clinical development planning activitiesRepresents GCSP on cross functional Clinical Matrix Teams and/or Project Teams. Leads cross-functional ad hoc teams to address urgent and important product safety issuesReviews and provides technical approval for investigator brochures, protocols, Informed consents, final study reports and external data monitoring committee charters. May lead or participate in discussion at Global Safety Board for safety related findings in clinical development. Presents safety information at clinical investigator and commercial meetingsEnsures prompt notification to TA Head of reviewed protocols that are identified as potential PASSEstablishes and chairs the Safety Review Team (SRT) for projects in development and provides expert review of data and management of safety issues. Escalates safety signals identified through the Safety Review Process to Global Safety Board if necessary, via the TA HeadAccountable for ensuring that risk reduction strategies are included in relevant documents such as clinical study protocols and/or product labelling, as appropriateProvides medical expertise for risk evaluation and risk management planningSignal Detection, Evaluation and LabellingDrives signal detection for assigned products using available methodologies (including On-Line Signal Management tool, literature review and tools for individual case awareness). Makes recommendations to SERM TA Director for the assessment and prioritisation of safety signals. Provides medical expertise to signal detection and subsequent evaluation for designated products in partnership with the responsible safety scientistProactively leads the