Dublin, Ireland
4 days ago
Associate Director, PV Regulatory Intelligence
Provide Global Regulatory Intelligence for Clinical and Post approval Pharmacovigilance for LCS and LCS Customers.ResponsibilitiesReview and scan Regulatory and organization’s websites for Regulatory Intelligence for Clinical and Post approval Pharmacovigilance in line with IQVIA procedures.Proactively monitor ICH, GVP, CIOMs and key agencies for draft legislation, supporting consultation opportunities where availableEntry and Quality Review of Global PV Regulatory Intelligence into IQVIA’s Regulatory Information DatabaseCollaborate with IQVIAs EU and Local QPPV network and local offices to collate data.Support Lifecycle Safety with RFI, RFP and BD activitiesBuild and maintain Commercial Model for provision of PV Regulatory Intelligence to LCS CustomersCollaborate with LCS departments to understand PV deliverables to ensure corresponding Regulatory Intelligence is available.Assess potential impact of regulatory changes on process or deliverables in collaboration with functional SMEs and/or Process excellenceLiaise with Business Development on proposal feasibilityLead bid defense strategy and planning for Regulatory Intelligence offeringMay act as primary interface for customersAttend internal and customer meetingsLead or support continuous improvement initiatives for processes and infrastructureLead or support implementation of innovative process, tech or AI for continual improvement. Support Lifecycle Safety Audits and InspectionsCross functional collaborationProvide coverage for Reg intelligence colleagues during absencesMentor, train and/or provide support and guidance to junior team members and peers

Minimum Required Education and ExperienceExperience: Minimum 5–7 years of relevant Pharmacovigilance experienceEducation: Bachelor’s degree (preferably in health science or related field)Additional Experience:5-7 years of relevant Pharmacovigilance experienceAt least 3 years of experience with assessing global PV Regulatory Intelligence5 years in Lifecycle Safety (e.g., Pharmacovigilance, CEVA, Medical Info, Safety Publishing, Risk Management)Equivalent combinations of education, training, or experience acceptedPractical knowledge of Global PV RegulationsSkills and AbilitiesIn-depth knowledge of Safety service lines, ICH guidelines, GVP modules, and regional requirementsAbility to gather and interpret regulatory informationStrong business acumen, financial managementProven leadership and motivational skillsStrategic planning, project management, and organizational skillsAbility to manage multiple delivrables and prioritiesEffective communication with senior stakeholdersCalm, assertive, and diplomatic in challenging interactionsExcellent verbal, written, presentation, and negotiation skillsStrong customer focus and account managementNetworking and meeting leadership skillsResults-driven in matrix environmentsCreativity, innovation, and problem-solving

This role is not available for a UK visa sponsorship.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

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