GAP provides Qualified Person for Pharmacovigilance (QPPV) services for clients who are entering in the European Union (EU) market to ensure a strong administration of Marketing Authorization Holder’s (MAH’s) pharmacovigilance frameworks in the EU. GAP QPPV will:
- Act as the essential and single purpose of contact to EMEA, other national established authorities, and for MAH which convey new and developing wellbeing concerns and rational analysis of risk/benefits to established authorities.
- Provides oversight of the MAH’s or customer’s safety platform, courses of action and techniques.
- Ensure execution and support of MAH’s pharmacovigilance systems and other risk management.
- Provide necessary information and skills for interpreting and applying various local and international safety regulations.
- Ensures all ICSRs are gathered, handled, and reported in accordance to the relevant EU administrative MAH commitments.
- Provide oversight of indicator recognition and compliance exercises
- Ensure well-timed submission of data reports such as Risk management findings, Post authorization study reports, PSURs and various documents which is required by EU authorities
- Instead of Marketing Authorization Holder’s (MAH), facilitates essential QPPV meetings to boost the knowledge with suitable regulatory authorities on signals undergoing evaluation, safety issues and regulatory safety issues and various features of PV systems and general risk management.
- Ensure plenty of quality control/assurance, arrangement, and measurement to contain standard operating procedures (SOPs) and instructions for work to cover-up all procedure relevant to pharmacovigilance.
- Expands pharmacovigilance quality auditing as per internal request or other regulatory authorities and improves the recommendation of auditing.
- Provides oversight together with the audits of Drug Safety Units (DSUs) and Marketing Authorization Holder’s (MAH) to make sure the observance to both company standard and different regulatory standard of EU.
Contact us for more information.