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Consumer Safety Science Director (non-MD)

Warren, NJ, New Jersey
Closing date
Jan 22, 2022

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Pharmaceutical, Pharmacovigilance, Physicians/Nurses
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Site Name: Warren NJ Posted Date: Dec 7 2021 *Remote Working Considered 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, Rx to OTC switch projects, in addition to maintenance of business activities for key company products. The Consumer Safety Science Director will: Serve as scientific safety lead for assigned Consumer Healthcare products. Lead safety strategy as member of R&D Innovation projects and Rx to OTC switch 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 KEY RESONSIBILITIES: Define safety strategy and provide strategic safety inputs into R&D innovation and switch 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. 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. 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 initiative Train, coach and mentor junior safety scientists in the scientific aspects of safety evaluations, signal detection and risk management methodologies Why You? Minimum Qualifications: Bachelor's degree in Healthcare or Life Sciences 7 plus years' experience in pharmacovigilance Experience with leading safety strategies for products involving Innovation and RX to OTC switch projects in consumer healthcare setting Experience in causality assessment, evaluation of safety signals and proactive risk management strategies including management of labelling changes Medical Writing Experience Knowledge of relevant regulations for all product types and methodologies applicable to safety evaluation & risk management activities Knowledge of pharmacology medical and drug terminology Preferred Qualifications: Advanced Healthcare professional degree or Life Sciences degree (PharmD, PhD) Consumer Healthcare Experience Experience of product safety related disciplines (e.g. clinical development, medical affairs, regulatory) Professional qualification as a healthcare professional, e.g. Pharmacist 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 Consumer Healthcare? Right now, we're on an incredible journey as we prepare to become the first independent, 100% focused consumer healthcare company. We're doing this at a time when the work we do has never mattered more. Better everyday health is about improving the health and wellness of the consumers that we touch every year - over a billion and a half of them - and it goes beyond products. It's about truly helping people manage their health proactively in different ways as consumer needs evolve. With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we're uniquely placed to do this and to grow a strong, successful business. This is an exciting time to join us and help shape the future. It's an opportunity to be part of something special. Diversity, Equity and Inclusion In Consumer Healthcare we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. *LI-GSK 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. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
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