About the role
The Operations and Support Specialist- Safety, supports the Consumer Safety team with operational use of Haleon’s safety systems to carry out the business functions of adverse event case management and submission to health authorities or license partners. The role will involve interaction with business users and Tech partners as a primary support role, including business user support, system configuration and enhancements, training, communications, and testing. User support includes request and issue resolution and general user assistance.
Key responsibilities
• Provides input and support on queries from business regarding adverse event case processing functionality.
• Gather user requirements and identify impacts on other components of the safety system environment.
• Work in close collaboration with Operations and Support colleagues to provide input on impact of enhancements and change requests across all systems and downstream.
• Accountable for resolving and escalating applicable incidents, act upon user requests in collaboration with Tech colleagues as necessary.
• Contribute to discussions with business stakeholders to understand business requirements, enhancements, and product roadmap, support the documentation of internal processes, user requirements, written standards, communications and training development and content.
• Participate in all aspects of informal testing and formal user acceptance testing for releases and changes.
• Support internal and external audit and HA and LP inspection requests as needed.
• Provide user guidance and support including access and incident management tasks.
• Responsible for deployment of expedited reporting rules and relevant organization and transmission profile configuration.
• Support E2B gateway connection, configuration and testing with external partners.
• Provide consultation and troubleshooting support for transmission failures, negative acknowledgements and other submission problems.
• Provide input as SME for the development, enhancement, implementation and maintenance of all impacted written standards and required training content.
Qualifications and skills Essential
• Bachelor’s degree in life sciences or information technology or other related area.
• 7 years pharmaceutical industry and/or consumer goods industry knowledge and experience with minimum 5 years in Pharmacovigilance.
• Mastery experience in Drug Safety System configuration, preferably Veeva Safety Vault system.
• Proficient knowledge in Pharmacovigilance and case processing.
• Experience with validated document management systems.
• Experience with supporting pharmacovigilance and safety system configurations and E2B R2/R3 connection and submissions.
• Proven understanding of the safety/pharmacovigilance processes and major agency regulations like FDA, EMA, PMDA, MFDS and NMPA, ICH GVP and GxP regarding systems validation and documentation.
• Track record of success in continuous improvement, innovative work practices and driving change.
• Experience of working within Agile delivery methodology with an understanding of the system development life cycle a plus.
• Knowledge of JIRA backlog and requirement management.
Preferred
• Technical background and computer proficiency in a variety of pharmacovigilance systems, report building capabilities and familiarity with MS O365.
• Excellent interpersonal and written and verbal communications skills with a proven ability to interact well with all levels.
• Ability to identify opportunities for process and compliance improvements.
• Enhanced customer service orientation and ability to communicate professionally to diverse cross-functional non-technical and technical audiences.
• Experience in work requiring attention to detail and excellent follow-up.
• Self-motivated, able to resolve issues with cross-functional teams with minimal supervision.