Local Safety Manager (Pharmacovigilance)

Local Safety Manager (LSM) / backup LSM protects public health through proactive approaches and innovative strategies for risk management by ensuring compliance with applicable regulations and high professional standards in collection, evaluation, and communication of safety information of its Medicinal Products, Medical Device and Drug/Device Combination Product throughout their life cycle and in collaboration among all Client regions and also with our business partners.

Individual Case Safety Report (ICSR) and Reconciliation

Collects, processes and forwards Safety Reports to Global Pharmacovigilance according to relevant global SOPs/WPs, Local SOPs/WPs, and applicable agreements. 

Performs follow-up on Safety Reports, including Pregnancy cases, as per relevant SOPs/WPs.

In case ICSR submissions to local Health Authority cannot be performed centrally (such as via E2B) or if local regulations require submissions to be performed locally, performs ICSR submissions to the Health Authorities as per applicable SOPs and agreements.

Conduct the monthly reconciliation according to relevant SOPs/WPs between PV and Medical Information (MI), Product Quality Complaint (PQC) or any other applicable data sources as applicable.

Safety Reporting (Significant/Emerging Safety Issue)

Reports the significant, Emerging Safety Issues to the Health Authority as required according to applicable SOP. 

PV Training 

Annual PV training plan setup.

Local PV training material development (including Basic PV training, PV trainings for studies/programs).

PV Related Agreement 

Preparation, review, update, and maintenance of PV clause in the agreement from PV perspective.

Reviews active local contracts <<specific frequency, e.g. annually>> to confirm that any PV-related activities in the contracts meet the latest Client Global Definitions Glossary and global/regional/local PV reporting requirements or standards. 

Informs relevant global/regional PV function immediately of any situations at the affiliate or contracted 3rd parties which prevent compliance with applicable PV SOPs, regulatory PV requirements and agreements.

Aggregate Report 

Manages and/or conducts oversight submission and archiving of received Aggregate reports (e.g., Periodic Safety Update Report, Periodic Benefit-Risk Evaluation Report, and/or Development Safety Update Report) if applicable. Submits the Aggregate Reports to the applicable local Health Authorities. Notifies the submission to the responsible local team and Global PV.

(RMP) Risk Management Plan

Manages and/or conducts oversight of RMP-related PV activities including Risk Minimization Measures.

Local Literature Search

Identifies Safety Information detected by local literature search based on Client Medicinal Products / Medical Devices, and sends the Safety Information according to relevant SOPs/WPs. 

Maintains a list of local journals selected (not listed in Medline, Embase or other global literature database) to be reviewed according to the applicable regional and/or local SOPs/WPs in the local search area and documents the search.

Study related responsibilities from PV perspective if applicable

Manages promotional materials (e.g., review, approval, etc.) from PV perspective.

Interface with Other Functions

Safety Information reconciliation with relevant team such as PQC, MI, and social media responsible person. 

Oversight of vendors performing PV activities on behalf of Client in accordance with applicable regulations, agreements, and SOPs/WPs.

Manages PV audit/inspection and ensures execution of deviation and Corrective and Preventative Action (CAPA) management.

Archiving

Ensures that all PV-related documents, including Safety Reports and associated documents and PV-related nominations are retained permanently. 

Regulatory Intelligence

Maintains current knowledge of all local regulatory PV requirements in the territory, communicates with relevant global/regional PV and ensures compliance with them.

PV Business Continuity Plan (PV BCP)

Development and maintenance of PV BCP in accordance with corresponding GSOP

Handover Management

Ensure handover management is appropriately conducted and documented per applicable GSOP.

Others 

Manages response to local Health Authority’s PV-related queries/requests according to relevant SOPs/WPs. 

Conducts oversight of any other PV related works as needed.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

Read Full Description