Webinar - The new QMS Normal Post COVID19 for the Pharma, Life Sciences & Medical Device Companies

Personnel Involved

PV Consultant & Auditor

  • Accountable for authoring global and regional PSMFs and ensuring ‘up to date’ and accurate content. Maintenance of the PSMF annexures and core body on a regular basis.

  • Actively coordinate with all the internal and external stakeholders to ensure Pharmacovigilance and regulatory compliance. Participate in the preparation of drafts for Standard Operating Procedures (SOP) and Work Instructions (WI) to ensure consistency, allocation of responsibilities, accuracy, timeliness and implementation.

  • Coordinate the preparation and conclusion of SDEAs together with relevant internal and external parties. Track and maintain oversight on all assigned Safety agreements.

  • Support the pharmacovigilance partner/teams to ensure that company continues to get the quality service from the vendor.

  • Answer queries from the Health Authorities related to products marketed by the Company in a scientific manner and support the necessary submissions with appropriate data.

  • Involvement in pre and post action arising from PV audits.

  • To update and review the GVP training material on an annual basis

  • For System Demo and further information, please call +91 98100 68241 or mail us at bd@crqa.in