Director of US Safety Operations

Site Name: USA - North Carolina - Research Triangle Park Posted Date: Apr 19 2022 As US Safety Operations Director, you will play a key role as main point of contact for local stakeholders regarding the implementation and interpretation of FDA regulations, serving as Subject Matter Expert for Safety Reporting Responsibilities. This role will provide YOU the opportunity to lead key activities to progress YOUR career. The following responsibilities apply to this role in relation to the US Safety Team: Perform impact assessment and drive implementation of new FDA regulations and ensure compliance with existing regulations as they apply to patient safety. Ensure the process for collection and reporting of HSI is aligned with US FDA and GSK Requirements. Responsible for local safety requirements related to Dear Investigator Letters (DILs) or Dear Health Care Professional Letters (DHCPLs). Serve as a local safety point of contact/liaison for internal and external stakeholders, including the FDA, Medical Affairs, Commercial, Regulatory Affairs, Regulatory Operations, Global Safety, Clinical Ops and Development. Serve as key member of any local product recalls and monitor for trends in product complaints as required per process. Perform safety operational activities allocated to the Named Safety Contact (NSC), and/or ensure appropriate delegation in consultation with the RPVD. Provide input into SDEA templates, Safety Management Plans or HSI contract language as related to US contracts. Serve as the local safety lead for local audits and inspections Serve as Subject Matter Expert for US Periodic and Expedited Reporting. Serve as the account manager for local safety vendor for any locally outsourced safety activities. Review global/local written safety standards, and provide input for local medical affairs activities related to patient safety as needed Maintain awareness and insight into REMS programs and escalate any safety issues as needed. 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. Strong knowledge of US periodic reporting (PADERs/PAERs, including requests for PBRER waivers). Strong knowledge of IND Safety Reporting requirements for FDA, especially with cross-reporting. Demonstrated experience interacting with cross functional stakeholders Experience with FDA inspections and audits. Excellent communication skills, both oral and written. Working knowledge of Microsoft office software (i.e., Excel, PowerPoint, Word) and database systems. Preferred Qualifications: Experience with REMS requirements and activities. Experience with negotiating Safety Data Exchange Agreements. Experience with managing product recalls. Knowledge of the FDA Combination Product Postmarketing Safety Rule. 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.