PLEASE NOTE: location is open to Global Remote locations

The primary purpose of this role is to support the Consumer Safety team on full life cycle of the system support in area of E2B configuration and gateway management activities. Responsibilities include but are not limited to E2B requirements analysis and development, transmission and gateway profile configuration, communication and coordination with internal and external trading partners, and remediation of E2B related issues and incidents.

Key Responsibilities

• Manage the EDI transmission and gateway profile configuration and lead as subject matter expert in E2B exchange implementation, data transfer protocols of AS1 and AS2, and routing and community setup.
• Responsible of E2B requirement analysis, data element customization and implementation with extended knowledge of ICH E2B (R2) and (R3) specifications and guidance, and FDA/EMA/PMDA and other major agencies regulatory guidelines on electronic submissions.
• Lead the communication with internal and external trading partners including regulatory authorities and license partners on gateway connection and submission exchange setup.
• Support EDI management and monitor E2B exchange status to ensure submission compliance.
• Analyse and provide root cause of E2B related incidents and issue as appropriate.
• Contributes to the creation of Standard Operating Procedures, Working Instructions, and Training materials concerning E2B configuration and submission monitoring.
• Strong knowledge of Axway, AWS cloud, and fluent in XML, SQL, PL/SQL. JSON is a plus.
• Understand pharmacovigilance reporting rules and timelines, drug development cycle, drug safety procedures/processes, and regulatory requirements.
• Support Drug Safety Dictionary version management such as MedDRA and WHO DD.
• Experience with safety database, preferably Argus Safety and/or Veeva Safety.
• Excellent in communication, collaboration, team playing, detailed-oriented tasks, and analytic and strategic thinking.
• Support case processing, compliance and case submission administration support to business users within the CH R&D organization including Consumer Safety PV Operations, Consumer Safety Sciences (CSS), Governance and Excellence, Regulatory, Quality and other business functions.
• Participate in discussions with business stakeholders to understand business requirements, document user requirements and participate in prioritizing the Backlog List, in collaboration with CH Tech partner.
• Ensure data quality standards are maintained through all system versions.
• Communicate important messages relevant to all levels of stakeholders, including content and plan of systems releases, issues, and change management.
• Manage the preparation, maintenance and execution of test scripts as required.
• Support Safety system functionality, user requirements and configuration request/specifications, plus risk assessment of impacts on other components and/or integrations within the system environment.
• Mentor, train and lead the junior members on safety operation and PV knowledge transfer. Support Audit/Assessment/Inspection readiness and participate in system internal audits and/or external inspections as needed.
• 7 years of PV Safety system operation, support and/or implementation experience with expertise in E2B configuration and relevant support tasks.

Why You?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's Degree
• 5 + years pharmaceutical industry and/or consumer goods industry knowledge and experience.
• Experience in a systems operations support role within safety/pharmacovigilance as business analyst or configuration support.
• Experience with Pharmacovigilance.
• Experience with validated document management systems.
• Experience with supporting safety systems.
• Experience and understanding of the safety/pharmacovigilance process and regulations, ICH GCP and GxP regarding systems validation and documentation.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Veeva Safety Vault experience a plus.
• Track record of success in continuous improvement, innovative work practices and driving change.
• Experience working within Agile delivery methodology with an understanding of the system development life cycle a plus.

Diversity, Equity and Inclusion

At Haleon 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. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Haleon offers a robust Total Reward package that consists of competitive pay and a comprehensive benefits program. This includes a generous 401(k) plan, tuition reimbursement and time off programs including 6 months paid parental leave. On day one, you are eligible for benefits, including our healthcare programs where the company pays for the majority of your medical coverage for you and your family. We also offer the opportunity to receive a discretionary bonus based on the achievement of key business performance and other incentive/recognition programs as part of the offering. The salary range for this role is: $110,000 - 130,000 or higher, depending on experience, plus 12% target bonus; this is applicable to US candidates only.

Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/

At Haleon 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. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

Haleon 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.

The health and safety of our employees are of paramount importance. 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.

We have 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.

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, Haleon may be required to capture and report expenses Haleon 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 Haleon’s compliance to all federal and state US Transparency requirements.