Safety Evaluation and Risk Management Director - Consumer Health

GlaxoSmithKline ,
Weybridge, Surrey
More Details

Overview

Job Description

As the Safety Evaluation and Risk Management Director (SERM), you will provide high level scientific expertise in the safety evaluation and risk management of key GSK assets or other highly complex products 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 provide global leadership of safety evaluation and risk management activities throughout the product's entire life cycle and shows confidence, credibility and influence at all levels of the organisation and, possibly, externally to GSK. Apart from the above, as the SERM Director, you will present the disease area or product area safety strategy at key internal GSK meetings, and fully represents GSK externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners. You may deputies for the PV Team Leader, and you may also participate in, or lead, cross-GSK activities such as safety advisory panels, interfaces with high levels of GSK outside CH SERM on a regular basis and may be recognized as a key player in external international pharmacovigilance activities Key Responsibilities: Safety Governance and Risk Management activities: * Leads thinking in CH SERM around risk management plans and their implementation. For designated products, drives Pharmacovigilance and Risk Management Planning in the clinical matrix and leads production of Global Benefit-Risk Management Plans * Leads safety input into regulatory benefit risk assessments, prepares the regional Risk Management Plans for designated products for submission to regulatory authorities * Delivers the clinical safety input into clinical development planning activities * Reviews 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 CH Safety & Labelling Committee (CHSLC) for safety related findings in clinical development. Presents safety information at clinical investigator and commercial meetings. Ensures prompt notification to SERM Head of reviewed protocols that are identified as potential PASS * CH SERM representative on cross functional clinical matrix teams and/or project teams. Leads cross-functional ad hoc teams to address urgent and important product safety issues * Establishes Safety Review Teams (SRTs) or co-ordinates leadership of multiple SRTs for projects in development and provides expert review of data and management of safety issues. Escalates safety issues identified through the Safety Review Process to CHSLC if necessary, via the SERM Head. Accountable for ensuring that risk reduction strategies are included in relevant documents such as clinical study protocols and/or product labelling, as appropriate Signal Detection, Evaluation and Labelling: * May be responsible for the signal detection and evaluation process of certain products within the SERM team, as delegated by the PV Team Leader. Drives 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 PV Team Leader for the assessment and prioritisation of safety signals within therapeutic area * Proactively leads the assessment of safety data and discusses the results with the PV Team Leader/ product physician. Effectively communicates with Clinical Development and other key stakeholders on signal evaluation and labelling recommendations * Leads presentations on labelling recommendations at CHSLC * Produces regulatory supporting documentation for labelling updates * Produces accurate and fit for purpose evaluation documents with clear conclusions, in response to internal or regulatory authority requests for safety data. Provides strategic input into regulatory requests for local label deviations from the company core data sheet * Conducts proactive signal detection and evaluation of issues potentially related to product defects or manufacturing issues; drives the escalation and resolution of issues and product complaints * In consultation with the product physician and Clinical Development representatives, prepares the Development Core Safety Information (DCSI) for assigned development products; co-ordinates and chairs meetings and tracks timelines to ensure completion Regulatory Reports and Submissions: * Drives production of periodic regulatory documents (PSURs, DSURs) according to the agreed process and timelines. * Acts as technical consultant on PSURs for key assets, overseeing strategy. May review PSURs, as delegated by PV Team Leader * Supports the Local Operating Companies by preparing license renewal documentati

People also viewed