
Medical Assurance Professional
1 day ago
Purpose And Scope
- Support the development, implementation, and successful execution of the Medical Assurance objectives, supporting the overall PV Case Management, RAPV Operations and RAPV mission.
- Contribute to driving a globally aligned approach to ensure ICSR medico-scientific quality and consistency, to support the effective management of the safety profile of Astellas marketed and investigational products.
- Collaborate with vendor medical personnel, Astellas RAPV and non-RAPV colleagues to ensure, support and improve processes to deliver high quality medico-scientific assessments for ICSRs.
- Maintain processes and tools to support high quality medico-scientific assessment of ICSRs
- Lead projects to establish and utilise effective systems to house regulatory documentation and support tools relevant for medical assessment case processing activities (including but not limited to RSI, Medical Concept Library and EPTLs).
Responsibilities And Accountabilities
- Oversee daily management of the Medical Assurance mailbox by team members through triaging, direct handling and flagging/distributing urgent and routine requests to relevant team members. Correspondence includes but not limited to potential safety issues originating from ICSRs, new/updated reference safety information and associated documents, product trainings and any question/request from Astellas RAPV/non-RAPV stakeholders or vendor staff pertaining to the medico-scientific aspects of ICSR processes and tools.
- Contributes to global (cross-functional) process improvement initiatives and projects impacting medico-scientific aspects of ICSR reporting, medical support tools and associated activities, and actively participate in cross-functional teams to represent the medical voice of the RAPV Operations organization.
- Contribute to the creation, maintenance, and optimization of PV Case Management medical support tools to ensure quality and consistency.
- Ensure effective and timely maintenance of the Medical Concept Library and Expected Preferred Terms Lists (EPTLs) to support expectedness assessments
- Lead medico-scientific activities for the biannual (twice a year) MedDRA updates
- Perform Medical Assurance activities for the maintenance of product labelling for Astellas marketed and investigational products, including the Reference Safety Information for clinical trials/studies.
- Supports (un)planned non-conformances and CAPAs and global quality improvement initiatives associated with medico- scientific aspects of ICSRs and related activities.
- Undertake impact assessments of non-conformances affecting ICSR case processing for Medical Assurance, including collaborating with other RAPV and non-RAPV colleagues, as required.
- Support regular and ad-hoc training and medical education to internal and vendor medical personnel on medico-scientific aspects of ICSRs, support tools and associated processes.
- Ongoing review and maintenance of quality documents owned by Medical Assurance.
- Support inspection readiness activities for topics associated with in-house and outsourced medico-scientific aspects of ICSR case management.
- Other tasks, activities or projects assigned by line manager, as appropriate
Required Qualifications
- Minimum BSc degree in life sciences, or equivalent
- Minimum 2 years case processing experience (post-marketing/clinical trial) and expertise within Pharmacovigilance, including seriousness, expectedness and causality assessments.
- Minimum of 5 years relevant experience in pharmacovigilance or combined PV/RA/QA, and/or clinical development
- Good understanding of safety regulations for both marketed and investigational products, and excellent knowledge of global health authority requirements including ICH, CFR 21, FDAAA, EU GVP module, JP regulations.
- Good knowledge of MedDRA dictionary for coding activities.
- A technical expert within the organization, with extensive knowledge within their chosen specialty and developing knowledge of related disciplines. Has the ability to recommend enhancements to internal policies, processes and procedures based on new requirements, legislation, etc.
- Provides solutions to a wide variety of problems of greater complexity that require the regular use of creativity and ingenuity, while safeguarding compliance and quality
- Experience in quality and process improvement activities
Preferred Qualifications
- Medical/physician qualification
- Advanced Excel skills, including development/usage of formulas and macros
Working Environment
Astellas' Global Capability Centres – Overview
Astellas' Global Capability Centres (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed.
_ _Our three GCCs are located in India, Poland and Mexico.
_ _
_ _The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.
_ _
_ _Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company's strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.
Category
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
-
Senior medical biller/ senior medical coder
3 weeks ago
Bengaluru, Karnataka, India Orchestrate Medical Full timeJob Title: Team Lead / Senior Medical Biller/ Senior Medical CoderLocation: Remote / BangaloreCompany: Dr New Med.com / Required: Minimum 7 yearsSpecialty Preferred: CardiologySoftware Expertise Preferred: Athena EHR & Next Gen HER is an added advantage. Job Summary:We are seeking a highly experienced and detail-oriented Medical Biller/Coder to join our...
-
Senior Medical Biller/ Senior Medical Coder
3 weeks ago
Bengaluru, Karnataka, India Orchestrate Medical Full timeJob Title: Team Lead / Senior Medical Biller/ Senior Medical Coder Location: Remote / Bangalore Company: DrNewMed.com / Experience Required: Minimum 7 years Specialty Preferred: Cardiology Software Expertise Preferred: Athena EHR & NextGen HER is an added advantage. Job Summary: We are seeking a highly experienced and detail-oriented Medical...
-
Medical Superintendent
3 days ago
Bengaluru, Karnataka, India Hire Xpert Full time ₹ 10,40,000 - ₹ 3,00,00,000 per yearKey Details:- Position: Medical Superintendent- Requirements: MBBS + MHA / MBA or equivalent- Experience: 8+ years- Location - Bangalore- CTC - Up-to 30LPA (Negotiable depends upon experience)- Reporting Authority - Chief Operating Officer.Responsibilities:- Strategic Leadership: Providing overall direction and vision for the hospital.- Operational...
-
Professional, Quality Assurance
3 days ago
Bengaluru, Karnataka, India JLL Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJLL supports the Whole You, personally and professionally.Our people at JLL are shaping the future of real estate for a better world by combining world class services, advisory and technology to our clients. We are committed to hiring the best, most talented people in our industry; and we support them through professional growth, flexibility, and...
-
Medical Transcriptionists
5 days ago
Bengaluru, Karnataka, India Weekday AI Full time US$ 40,000 - US$ 80,000 per yearThis role is for one of the Weekday's clientsMin Experience: 3 yearsLocation: BengaluruJobType: full-time We are seeking highly skilled and detail-oriented Medical Transcriptionists with 3 to 20 years of experience to join our healthcare documentation team. The ideal candidate will possess strong expertise in transcribing medical dictations accurately and...
-
API,Rest Assured Professional
1 week ago
Bengaluru, Karnataka, India IDESLABS PRIVATE LIMITED Full time ₹ 15,00,000 - ₹ 25,00,000 per yearWe are looking for a skilled professional with 6 to 12 years of experience to join our team in the API and Rest Assured domain. The ideal candidate will have a strong background in this area.Roles and ResponsibilityDesign, develop, and test APIs using Rest Assured.Collaborate with cross-functional teams to identify and prioritize project requirements.Develop...
-
Medical Transcriptionist
6 days ago
Bengaluru, Karnataka, India Spandana Hospital Full time ₹ 2,00,000 - ₹ 6,00,000 per yearCompany OverviewSpandana Hospital is a premier institution delivering world-class healthcare services dedicated to affordability and excellence. Situated in Bangalore, we at Spandana heart and superspeciality hospital pride ourselves on our highly trained team and our commitment to patient-centered, high-quality tertiary and critical care. We aim to stand at...
-
Clinical Quality Assurance Officer
3 weeks ago
Bengaluru, Karnataka, India Weekday AI Full timeThis role is for one of the Weekday's clientsMin Experience: 5 yearsLocation: BengaluruJobType: full-timeRequirementsJob Description- Review diagnostic reports for accuracy, completeness, and compliance with medical standards.- Perform quality assurance (QA) checks on CT and MRI medical images reported by radiologists.- Collaborate with radiologists to...
-
Professional, Quality Assurance
5 days ago
Bengaluru, Karnataka, India JLL Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJLL empowers you to shape a brighter way. Our people at JLL and JLL Technologies are shaping the future of real estate for a better world by combining world class services, advisory and technology for our clients. We are committed to hiring the best, most talented people and empowering them to thrive, grow meaningful careers and to find a place where...
-
Clinical Quality Assurance Officer
1 week ago
Bengaluru, Karnataka, India Weekday AI Full time ₹ 6,00,000 - ₹ 12,00,000 per yearThis role is for one of the Weekday's clientsMin Experience: 5 yearsLocation: BengaluruJobType: full-timeRequirementsJob Description Review diagnostic reports for accuracy, completeness, and compliance with medical standards. Perform quality assurance (QA) checks on CT and MRI medical images reported by radiologists. Collaborate with radiologists to...