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Director, US Safety Compliance

Research Triangle Park, NC
Closing date
May 20, 2022

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Other, Legal/Regulatory Affairs
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Site Name: USA - North Carolina - Research Triangle Park Posted Date: Apr 21 2022 Are you energized by the opportunity to implement and impact key functions that will ensure quality and compliance pertinent to US Safety regulations and standards? If so, this US Safety Compliance Director role could be an ideal opportunity to explore. As US Safety Compliance Director this role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Ensure that KPIs related to FDA and License Partner reporting compliance and quality, are monitored and tracked, review trending analysis, and escalate issues as needed. Serve as the local compliance point of contact for Global Safety and for other functions in R&D. Own the impact assessment and local implementation of global written standards, including the authoring/ maintenance of local standards as needed (including safety activities for USMA written standards). Perform periodic review and updates to local country SOP/Manual and implement safety activities, including training to local teams as required. Perform safety compliance activities allocated to the Named Safety Contact (NSC), and/or ensure appropriate delegation in consultation with the RPVD. Act as the local Record Retention Champion/Steward to ensure adherence with GSK's Record Retention Policy. Ensure there is a robust process for management of the US Safety Mailboxes and that the US Contact details are kept up to date in the LOC Contact List and elsewhere as appropriate. Serve as the primary contact for Independent Business Monitoring (IBM) activities, including, but not limited to local Risk. Management, Management Monitoring, Training, Communication and Written Standards in support of the overarching Internal Control Framework. ~This includes processes and systems to ensure completion of annual training on HSI for internal and external audiences and collect and monitor compliance of this training. Perform local issue management activities, including SQIs, and escalate to RPVD as needed. Author and track CAPAs and to confirm the root cause/issue was addressed. Serve as the local safety point of contact for local audits and inspections. Implement business continuity plans for US reporting-related requirements for HSI. Drive the implementation of transformational projects or other process improvement initiatives in the US Safety Team. Perform delegated activities from the US Regional PV Ops Director or other US Directors as requested. Why you? We are looking for professionals with these required skills to achieve our goals: Basic Qualifications: Minimum 7 years' experience in Pharmacovigilance, including 3+ years' experience working with US regulations and/or GxP requirements. Strong knowledge of US pharmacovigilance regulations for investigational and post-marketing requirements. Demonstrated experience interacting with cross functional stakeholders, including senior leaders. Experience interacting with the FDA and other regulatory authorities Experience with participation in audits. Experience with CAPA management - including performing root cause analysis. Ability to review and interpret KPIs. Ability to manage and influence cross functional teams High attention to detail. Excellent communication skills, both oral and written. Proficiency in Microsoft office software (i.e., Excel, PowerPoint, Word) and database systems. If you have the following characteristics, it would be a plus: Preferred Qualifications: Experience with Quality Management Systems, Veeva a plus. Experience in authoring and implementing SOPs/written standards. Experience with issuing and managing training plans for third parties/commercial teams. 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. #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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