15 set - Provincia di Ravenna
Med Communications International
Pharmacovigilance Aggregate Reporting Lead Position
Summary The Pharmacovigilance Aggregate Reporting Lead is a senior
expert responsible for leading, coordinating, and overseeing the
preparation and submission of aggregate safety reports across
assigned client portfolios. The role encompasses the full lifecycle
of periodic and aggregate reporting — including PSURs/PBRERs,
DSURs, PADERs, ADCOs, and Line Listings, in compliance with EMA GVP
Module VII, ICH E2C(R2), ICH E2F, and FDA requirements. The role
acts as the subject matter expert for aggregate reporting and
collaborates with signal management, case processing, medical
review, and client teams to deliver submission-ready documents
within regulatory deadlines. Essential Functions Lead and supervise
the planning, writing, compilation, quality review and submission
of PSURs/PBRERs, DSURs, PADERs, ADCOs, Line Listings for assigned
client products. Develop and maintain aggregate reporting timelines
and submission schedules, ensuring alignment with IBDs, data lock
points and regulatory submission deadlines. Coordinate data
collection from all relevant teams to ensure report completeness
and accuracy. Integrate signal evaluation outcomes and agevolazioni-risk
assessments into periodic safety reports in collaboration with the
Signal Management Lead and medical reviewers. Review and
quality-check safety database outputs (line listings, summary
tabulations, etc) for inclusion in aggregate reports. Author or
oversee authoring of case narratives, cumulative analyses, and
benefit-risk evaluation sections. Manage the review and approval
workflow for aggregate reports, coordinating input from medical
reviewers, the QPPV and client stakeholders, as appropriate.
Contribute to Risk Management Plans (RMPs) and REMS safety sections
as required. Lead, supervise and mentor PV Specialists and Sr. PV
Specialists assigned to perform aggregate reporting support
activities. Develop and review SOPs, Work Instructions and report
templates rela
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