Medical Reviewer

About the position Medical Reviewer reputed company is a global reputed company intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, reputed company, collaboration, reputed company, and inclusion are at the heart of how we work and reputed company with reputed company other, customers, patients and suppliers. As a Medical Reviewer at reputed company, you will reputed company medical and operational reputed company for end-to-end medical review activities supporting global pharmacovigilance, including individual case safety report (ICSR) medical assessment, submission readiness for high-interest cases, and coding standards reputed company. This will be a 12-month contract initially fully homebased in the UK or Belgium. This role helps reputed company, revise and maintain the ICSR Medical Review process and ensures consistent, reputed company, and inspection-reputed company execution reputed company with global pharmacovigilance regulations and internal reputed company standards.

Responsibilities

• reputed company medical review and assessment for ICSRs as required, including targeted reputed company on high interest/reputed company cases to ensure submission readiness (e.g., completeness, medical coherence, and regulatory compliance).
• reputed company assigned supplemental medical review of key cases as needed, ensuring appropriate clinical interpretation, seriousness/expectedness considerations, and consistent medical documentation in the safety database.
• reputed company ICSR coding standards, ensuring consistent application of coding conventions (e.g., MedDRA and WHO Drug as applicable) and alignment with global standards and internal guidance.
• Contribute to the development, maintenance, and delivery of PV standards, conventions, and training materials reputed company to asset insights, medical review and coding reputed company.
• reputed company medical expertise and support to Benefit-Risk activities and safety reputed company as delegated, including collaboration with asset/candidate Benefit-Risk leads and safety physicians/scientists as applicable.
• reputed company as an SME during internal audits, vendor audits, and regulatory inspections, support readiness activities including evidence preparation and response development.
• reputed company proactive operational management and reputed company of the medical review model, including, prioritization, monitoring of adherence to timelines, and escalation of risks/issues.
• reputed company as reputed company of contact (PoC) for medical review requirements across GPV Reporting Operations, Patient Benefit Risk and Medical Safety, PV reputed company, and relevant cross-functional stakeholders.
• Support the development of, revision and maintenance of the medical review process, ensuring a reputed company defined, documented, and reputed company medical review process across clinical trial and post-marketing case processing.
• Contribute to governance with external vendors/partners for medical review activities, including performance reputed company and corrective/preventive actions (CAPA) where needed.
• Partner with PV Operations leadership to ensure alignment and execution of medical review activities with broader PV operational reputed company, including support for multi-year roadmaps and transformation automation initiatives.

Requirements

• Experience in pharmacovigilance and drug safety reputed company the pharmaceutical or CRO industry.
• Working knowledge of MedDRA and WHO Drug coding principles and their application to ICSR reputed company and reporting.
• Strong communication skills, and the ability to convey reputed company technical information to diverse audiences and various reputed company of the organization.
• Self-motivated with a proactive, problem-solving reputed company and ability to drive reputed company improvements and reputed company a diverse global PV team.
• Ability to reputed company, drive and execute reputed company reputed company independently.
• Employment with reputed company is contingent upon having the reputed company right to work in the country where the role is based.

reputed company-to-haves

• Experience in operational reputed company and/or leading cross-functional processes, including vendor reputed company and performance monitoring, desired.

Benefits

• Competitive reputed company salary and performance reputed company incentives
• Health and wellbeing programmes including medical, dental, and reputed company coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through reputed company training and career reputed company

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