Business Title Periodic Reporting Expert Oversight

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

The PRE Oversight role is the centralized function with expertise on the regulatory framework and is the process owner for Global PSRs (e.g. PBRERs, Semi Annual Safety Reports {SASR}, DSURs, Product renewals (Addendum for Clinical Overview {ACO}), PADERs, etc.).
• Provides Global PSR format training to new and contributors, provides mentorship for new PREs;
• SME in inspections, internal and partner audits to communicate PSR processes and expectations as defined in quality documents;
• Implements process and quality document changes when regulatory requirements change or process improvements are identified;--Coordinates, collects contributions from regulatory and clinical departments, obtains cumulative exposure data, authors the pharmacovigilance content either alone or in collaboration with GSOs (Global Safety Officers), including signal detection analyses, RMP information, and compiles all information received and/or authored into a final document ready for publishing;
• Expert in systematically assessing relevant product content for inclusion in PSRs from available regulatory and product monitoring documentation;
• Leads and manages the cross-functional coordination of PSRs and Pharmacovigilance contribution to PSRs to ensure regulatory submission compliance;
• Oversees the coordination, collection, and authoring of Global PSRs by vendor according to an existing outsourcing strategy, provides the necessary training, mentorship, and provides constructive feedback to ensure adherence to quality document requirements; ensures self QC and peer QC is documented and fed through the quality improvement process;
• The PRE is expected to foster productive relationships with cross-functional teams that appropriately represent the PRE team as a whole;
• Accountable for complying PSR timelines, accurate tracking of contributions from contributors and communicating report quality expectations;
• Responsible for management escalation regarding non-compliance to PSRs timelines, quality expectations, and procedures and or reports that are at risk for being late for completion and distribution/submission;
• Accountable for the maintenance of the appropriate documentation utilized during Global PSR authoring in customer’s document management system;
• Participates in Health Authority assessment report responses in collaboration with the GSO and QPPV as it relates to Pharmacovigilance content as well as with regulatory and other stakeholders;
• Coordinates and participates in responding to health authority and partner questions regarding the Global PSR content and processes;
• Responsible for PSR quality and compliance oversight and continuous improvement of processes;
• Accountable for complying to timeline expectations and for the accurate and reliable tracking of quality and compliance metrics for Global PSRs;
• Supports/provides the root cause analyses associated with quality and compliance deviations.
• trains and mentors new staff

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