Vaccines SERM Medical Director and Team Leader
Site Name: USA - Maryland - Rockville Posted Date: Jul 14 2021 Are you a safety/pharmacovigilance physician with in-depth and hands-on experience, looking to lead and develop a great team? Reporting into the US SERM Vaccines Head, the SERM Vaccines Team Leader will have the opportunity to lead the surveillance of the safety profiles of a group of GSK vaccines, both under development and marketed, within his/her team by taking responsibility for the efficient and appropriate evaluation and aggregate review and reporting of all adverse events and at risk reports received by GSK vaccines. You may also have responsibility for the overall safety evaluation and risk management of one or more products within the portfolio. The Team Leader has management responsibility for a team of scientific and medical staff within the SERM, wherever they may be sited (global virtual team management). You will also manage all safety aspects within its portfolio during all phases of development and commercialization. GSK considers the clinical safety of its products to be of paramount importance. As a Safety Pharmacovigilance Director, you will play a key role in supporting the Central Safety Leadership Team, and the broader business at both a strategic and operational level. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Safety Governance and Risk Management activities - Leads thinking in VCSP 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 Global Safety Board for safety related findings in clinical development. Presents safety information at clinical investigator and commercial meetings. Ensures prompt notification to TA Head of reviewed protocols that are identified as potential PASS - VCSP 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 Global Safety Board if necessary, via the TA Head. Accountable for ensuring that risk reduction strategies are included in relevant documents such as clinical study protocols and/or product labelling, as appropriate - Provides medical expertise for risk evaluation and risk management planning Signal Detection, Evaluation and Labelling - Overall responsibility for the signal detection and evaluation process of a group of products within the SERM portfolio, as delegated by the SERM Vaccines Head. 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 SERM TA Director for the assessment and prioritisation of safety signals within therapeutic area - Provides medical expertise to signal detection and subsequent evaluation for designated products in partnership with the responsible safety scientist - Proactively leads the assessment of safety data and discusses the results with the SERM TA Director/ product scientist. Effectively communicates with Clinical Development and other key stakeholders on signal evaluation and labelling recommendations - Leads presentations on labelling recommendations at Global Labelling Committee or Global Safety Board - Produces regulatory supporting documentation for labelling updates - Provides medical sign-off for regulatory documentation and represents GCSP as the medical member of labelling discussions - 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 scientist 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, Annual Reports) according to the agreed process and timelines. Acts as technical consultant on PSURs for key assets, overseeing strategy. May review PSURs, as delegated by TA Director - Supports the Local Operating Companies by preparing license renewal documentation (e.g. PSUR addenda line listings, clinical overviews, summary bridging reports) as required for each market - Accountable for medical input, review and sign-off of periodic reports (e.g. PSURs) and renewal documentation submitted to regulatory agencies - Leads the SERM safety component of global regulatory submissions for new products, formulations or indications, with liaison with other functional experts Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: - Medical Degree, Board Eligible or Certified. An additional degree (e.g. PhD, MBA, MSc, MPH) or specialization is a plus. Clinical practice experience after medical training, or other relevant experience requiring medical judgement and ability to make medical decisions. - Minimum 3 years prior experience in biopharmaceutical industry pharmacovigilance. - Previous managerial experience is an asset. - Expert knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities - Expertise in causality assessment, evaluation of safety signals and proactive risk management strategies including management of labelling changes, physician and patient education. Likely to be recognised as an authority in this area at high levels within GSK outside of VCSP and possibly in the external international pharmacovigilance arena - Expert evaluation skills and analytical thinking - In depth knowledge of other related disciplines, e.g. statistics, epidemiology relevant to assessing drug utilisation and safety at the population level - In depth knowledge of clinical development process - In depth understanding of drug approval process in major countries - Outstanding medical writing skills - Sound computing skills Preferred Qualifications: If you have the following characteristics, it would be a plus: An additional degree (e.g. PhD, MBA, MSc, MPH) or specialization is a plus Ability to effectively influence key stakeholders at all levels of the organization Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *This is a job description to aide in the job posting, but does not include all job evaluation details. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. 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