Periodic Report Exp Oversight

4 days ago

Remote, India IQVIA Full time

Provides Global PSR format training to new staff and contributors, provides mentorship for new PREs.
- SME in inspections, internal and partner audits to communicate PSR processes and expectations as defined in QDs.
- Implements process and QD changes when regulatory requirements change, or process improvements are identified.
- Coordinates, collects contributions from regulatory and clinical departments, obtains cumulative exposure data, authors the PV content either alone or in collaboration with GSOs, including signal detection analyses, Risk Management Plan (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 PV 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 QD requirements; ensures self-Quality Control (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.
- 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 Sanofi’s document management system.
- Participates in HA assessment report responses in collaboration with the GSO and Qualified Person for Pharmacovigilance (QPPV) as it relates to PV content as well as with regulatory and other stakeholders.
- Coordinates and participates in responding to HA 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.
- Provide or receive training on Customer-specific processes, systems, or products.
- Other tasks as required.

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