Pharmacovigilance Regulatory Reporting

**Job Overview****Essential Functions**- Assess Lifecycle Safety data for reportability to relevant authorities, including EudraVigilance, and track reportable cases.- Report to regulatory authorities, ethics committees, institutional review boards, investigators, and oversight groups per legislation, within timelines, and in a format compatible with...

**Job Overview** - As a Regulatory Reporting Specialist, you will be involved in submitting safety reports to regulatory authorities._ Review, assess, and process safety data and information received from various sources. Distribute reports/data to internal and external third parties following applicable regulations, Standard Operating Procedures (SOPs),...

**Job Overview** We are seeking a dedicated and detail-oriented professional to join our team as a Operations Specialist 1. In this role, you will provide critical phone support to healthcare professionals and patients, handling medical inquiries, adverse events, product quality complaints, and other relevant calls. This position does not involve commercial...

IQVIA is #hiring for the best talent for the pharmacovigilance team! **Main responsibilities**: - Translation management as applicable, local case narrative writing as required. - Local material translation/customization as applicable. - Translation management into required language to local templates. - Support all operations related to the team including...

**Your responsibilities will include**:- Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.- Database entry and determining initial/update status of incoming events.- Coding AE and Products, writing narratives, literature related activities, quality review, assisting with...

**Job Overview** Manage the administrative support for deliverables across the Safety Aggregate Reporting and Analytics (SARA) services, as appropriate. SARA deliverables include safety aggregate reports, literature surveillance, signal detection and benefit risk management services. **Essential Functions*** - Schedule meeting. - Take meeting notes and...

Job Overview Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team...

**Job Overview**Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements.**Essential Functions**- Act as primary author & or reviewer/QCer of SARA deliverables involving aggregate reports, signal management or literature review projects.- Lead, author...

Job OverviewServe as principal owner of the SARA deliverable and have responsiblility for completion of the deliverable in compliance with all applicable service level agreements.Essential Functions- Act as primary author & or reviewer/QCer of SARA deliverables involving aggregate reports, signal management or literature review projects.- Lead, author and...

Viatris Healthcare México S. de R.L. de C.V At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted...