PVQA Manager

Site Name: USA - North Carolina - Research Triangle Park, UK - Hertfordshire - Stevenage, UK - London - Brentford, USA - Pennsylvania - Upper Providence Posted Date: Jan 20 2022 Are you interested in a Pharmacovigilance QA role that allows you to make an immediate impact to the business? If so, this Manager PV QA could be an ideal opportunity to explore. The purpose of this role is to provide PV Quality Assurance within GSK R&D, by providing input into the development, management, and implementation of strategies and initiatives, policies and procedures to support the PV audit program across GSK R&D. Identify compliance issues, monitor trends, be accountable for driving quality improvements back into Global Safety and improve PVQA processes. Lead holistic QA activities by supporting the business as well as involvement in PV regulatory inspections. Build solid working relationships with Global Safety stakeholders to build network of contacts, and maintain knowledge of local regulatory frameworks and global regulatory reporting requirements. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Assist in the development, management, and implementation of strategies and initiatives, policies and procedures to support the PV audit program Develop, implement and assess PV quality assurance strategies, organizational and operational needs. Primary internal customer base includes Global Safety, LOCs, Safety Governance, Risk Management, QPPVs, GRA Independently manage comprehensive PV/MV quality assurance programs and assess adherence to quality standards and compliance with PV/MV, International regulations and Guidelines, and GSK policies and procedures. Independently plan, lead, and conduct routine and complex audits of PV activities within Global Safety, LOCs, External Service Providers and Licensing Partners to assure compliance with PV regulations, GSK policies and procedure, and applicable local regulations. Lead PV consultancy efforts with Business Units and / or regions, as appropriate Pro-actively perform as a risk-management consultant, providing expert advice in relation to obtaining compliance, quality improvement, holistic quality initiatives, and risk assessment Collaborate with Global Safety staff to interpret international regulations and guidelines and establish and monitor compliance for acceptable standards for PV/MV activities Responsible for training and providing feedback to peers Act as inspection coordinator for PV related regulatory authority inspections of GSK Generate and provide metrics, status and periodic reports and other information to identify trends and develop improvements across the business Act as a consultant and represent PVQA to central and local safety teams in relation to compliance, quality improvement, business redesign initiatives and risk assessment Provide expert advice in relation to obtaining compliance, quality improvement, process and program initiatives and risk assessment, and act as point of contact for customers and CQA staff for PVQA Maintain an up-to-date and in-depth knowledge of appropriate national and international PV/GCP legislation and guidelines that affect the business Maintain an in-depth knowledge of PV processes and procedures Develop and maintain a network of contacts with other quality and compliance groups as well as client areas Educate, guide and influence GSK management and staff on best quality and compliance practices, especially as they relate to areas of identified responsibility Build and maintain beneficial working relationships with all internal and external customers Support the recruitment of new PVQA staff Develop PV training program to PVQA advisors Interact with regulatory agencies in designated region(s) as appropriate or as needed Develop PV training program to PVQA advisors Interact with regulatory agencies in designated region(s) as appropriate or as needed Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in related Life Science, Pharmacy, or related discipline. Equivalent experience will be considered Three or more years scientific/pharmaceutical industry experience in pharmaceutical research and drug safety Two or more years experience with Good Pharmacovigilance Practice Compliance, Good Clinical Practice Compliance and/or Quality Assurance, or Drug Development Ability and desire for frequent domestic and international travel (approximately 25-40%) Preferred Qualifications: If you have the following characteristics, it would be a plus: Master's degree in Life Sciences or related discipline Expert knowledge of global, regional and national PV regulatory requirements and regulations Detailed knowledge of the drug/clinical development processes and R&D Systems Detailed knowledge of pre and post marketing PV/MV activities associated with different areas of the business (e.g., clinical trials, manufacturing, regulatory affairs, commercial, toxicology) Self-motivated and quick learner who proactively shares knowledge and welcomes knowledge and feedback from other team members· Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. *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. 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