Consumer Safety Science Director
Site Name: USA - New Jersey - Warren Posted Date: Nov 23 2021 Consumer Healthcare has a large portfolio of products including medicines, cosmetics, medical devices and dietary supplements. In line with a risk-proportionate framework for product vigilance, the Consumer Safety Science Director is accountable for defining and driving the safety strategy for R&D innovation projects as well as maintenance of business activities for key company products. The position holder will: Serve as scientific safety lead for assigned Consumer Healthcare products. Play an important role progressing switch opportunities by supporting the activities of the Switch team to develop and execute robust safety strategies that leverage advancing science and research techniques. This includes anticipating and identifying safety data needs to support product approval; and, advising on the design of label comprehension studies, self-selection studies, actual use trials, in addition to development of integrated safety summary. Lead safety strategy as member of R&D Innovation projects. Serve as member to product incident team and provide safety risk impact statements. Provide safety input to due diligence activities. Ensure that the strategic R&D planning is aligned with safety objectives Show agility, confidence, credibility and influence at all levels of the organization For MD holders, additional responsibility will include signature on regulatory documents requiring approval by medically qualified personnel. Define safety strategy and provide strategic safety inputs into R&D innovation projects for all CH product types (e.g. medicines, medical devices, cosmetics, dietary supplements, digital projects) within assigned therapeutic category and represent safety function at project teams and other relevant cross-functional fora. Define safety strategy and provide strategic safety inputs into R&D innovation projects for all CH product types (e.g. medicines, medical devices, cosmetics, dietary supplements, digital projects) within assigned products and represent safety function at project teams and other relevant cross-functional fora. Ensure a fit-for-purpose (FFP) approach for safety inputs into maintenance of business activities Conduct proactive signal detection and management activities for assigned products. Make recommendations to safety management on prioritization, assessment and escalation of safety signals. Drive implementation of risk minimization activities in a FFP manner, including umbrella brand framework and product labelling updates Lead evaluation of safety issues related to product defects at manufacturing sites Provide strategic safety guidance for development of regulatory documents and responses to boards of health Represent the company at meetings with regulatory agencies and other companies. Lead safety inputs in due diligence activities by providing expert safety assessments and recommendations Drive improvements to the existing operating model and lead implementation of new techniques and initiatives Train, coach and mentor safety associates in the scientific aspects of safety evaluations, signal detection and risk management methodologies Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Degree in Biomedical or Healthcare related specialty Expertise in causality assessment, evaluation of safety signals and proactive risk management strategies including management of labelling changes, physician and patient education Outstanding medical writing skills Sound computing skills Expert knowledge of relevant regulations for all product types and methodologies applicable to safety evaluation & risk management activities Sound knowledge of the assigned therapeutic area In depth knowledge of medical and drug terminology and a sound foundation in pharmacology Preferred Qualifications: If you have the following characteristics, it would be a plus: Medical Degree or Advanced Degree Life Sciences Experience of product safety related disciplines (e.g. clinical development, medical affairs, regulatory) preferred Professional qualification as a medical doctor or other healthcare professional, e.g. Pharmacist may be advantageous Demonstrated track record of quality decision making and problem resolution based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context Excellent leadership skills in the matrix team setting. Proven ability to train, coach and mentor Ability to manage and co-ordinate tasks, projects and processes across a large organisation Highly effective communication skills; able to present complex data to groups at all levels of the organisation and external to the company Highly developed negotiation and influencing skills Demonstrated ability to prioritise multiple tasks and deliver to deadline with high standard of quality Contributes innovative ideas to address new issues or improve approaches to existing operations Ability to adjust behaviours and priorities based on changing environment Demonstrated ability to think tactically and strategically and take account of internal/external environment when considering safety issues and business processes Ability to engage in, and contribute to the broad R&D organisation with confidence, impact, integrity and professionalism 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. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. 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