Senior Medical Information Manager

Benefits

Additional Information

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs. Job Summary The Senior Medical Information Manager is responsible for: Independently developing and managing multiple teams of Medical Information professionals to support the delivery of high quality, efficient and cost-effective Medical Information enquiry handling service on behalf of designated clients. Leading process improvements to ensure that the service provided is of the highest quality and as cost effective and efficient as possible. Becoming involved in the full range of services, as delegated by Senior Management. Essential Functions Medical Information service delivery Independently provide oversight and direction to Medical Information teams to provide high quality and efficient medical information enquiry handling service, including ensuring workload is distributed effectively. Responsible for maintaining standards of quality and productivity in alignment with global Standard Operating Procedures (SOPs), regional SOPs and other working processes and policies. Oversee management of client Medical Information inquiries, including responsibility for ensuring the team recognise adverse events and defective product reports and report these in strict compliance with ProPharma SOPs and Working Practices. Communicating excellently with Company clients as appropriate. Make decisions consistent with company guidelines and policies. Serve as expert Medical Information resource for internal staff and clients. Continually seek out ways to enhance customer service experience both internally and externally. Business Development Represent ProPharma in Medical Information related corporate activities including prospective client meetings and client implementations. Collaborate with Client Services team and participate as Medical Information resource during new client implementations. Quality Assurance Ensure teams meet KPIs and SLAs for assigned programs, as documented in SOPs and Working Practices and feeding back to the team on improvements needed or providing positive feedback as required. Ensuring the team maintain quality in all areas of the job, particularly reporting of Adverse Events, Product Quality Complaints, and logging enquiries into the Enquiry Handling System. Ensure Quality investigations and process improvement strategy are completed. Able to act as Entrusted Safety Control Implementation Supervisor (ESCIS, or equivalent) if the person has Engaged for at least 3 years in safety assurance work or related work The ability to properly and smoothly undertake safety assurance activities Acting as Entrusted Safety Control Implementation Supervisor (ESCIS) is meeting requirement pursuant to Ordinance of the Ministry of Health, Labour and Welfare (MHLW) No. 135 of 2004 Article 98-2 of the Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices Personnel Management and Training Coach, mentor, motivate and develop staff. Foster teamwork and collaboration. Resolve conflict and lead performance/disciplinary meetings as required. Monitor and provide staff ongoing performance feedback and conduct annual performance and compensation reviews. Planning headcount requirements and tracking theses against team workload to fully justify any necessary headcount increases. Recruitment of new staff as required. Identifying training needs of the team and ensuring these are met. Planning comprehensively to ensure continuity of services, communicate needs of the department and provide recommended solutions. General Develop, maintain and lead Medical Information department operations and process improvement strategies, including updating of company and client documentation and training materials. Involvement in critical projects essential to MI function, as required. Taking the lead for the department in times of critical client issues e.g. when the Business Continuity Plan is invoked or when workload increases dramatically. Ensuring that any confidential information or personal data related to ProPharma, and its clients is managed in accordance with Data Privacy regulations as described in ProPharma SOPs. Occasional corporate business travel may be required. Other duties as assigned. Necessary Skills and Abilities: A sound knowle

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