Compliance in Pharmacovigilance by
Marketing Authorization holders and vendors
MAH needs to oversee its pharmacovigilance even if it has outsourced it to vendors. We all know this, but the implementation is critical.
The oversight starts with choosing the right vendors and ensuring checks and balances are in place. Vendors also need to have a robust and efficient partnership with their clients, going beyond just providing services to being partners. How do both achieve this synergistically?
Process level requirements:
- An SOP should be in place at the QA level that describes the vendor selection process, selection criteria, and onboarding.
- This SOP is at the company level and needs to be modified by the pharmacovigilance department/function.
- Mandatory audits along with the noted deficiencies and their corrective and preventive actions with timelines were conducted.
- Quality monitoring metrics need to be in place for each activity that is outsourced e.g. ICSR quality metrics, PSUR quality checklist
- The statement of work should be as clear as possible
- Safety management plan- detailing for each activity (e.g., diagrams) how the ICSR workflow looks between MAH and vendor from receipt to submission. The same level of granularity is for aggregate reports from a kick to submission, signal detection, literature, HA requests, etc
- Vendors must prepare client-specific documents, such as safety management plans, training presentations, QC checklists, and work instructions.
- Frequency of meetings and collaborations with various levels of team involvement, e.g., governance meetings with senior leadership, which can be quarterly, weekly meetings with the operational team, etc.
- Monitoring plan that includes Key performance indicators that will be monitored, process, SOP, etc
- Training requirements need to be fully discussed, and a training plan that will help frequent upgrades and awareness of vendor team on MAH's changing process needs to be in place
- Team details (org chart, CV, JD) need to be made available at least for critical roles
Metrics and beyond for effective PV systems and functions
A vendor—MAH needs to be open, transparent, and honest with each other. Leadership plays a vital role here. Having frequent connections and dialogues helps immensely.
An MAH needs to understand and respect Vendors' opinions and suggestions. A vendor also needs to take a tailor-made approach when needed to meet MAH, where they have scientific justification for doing things according to their products.
Frequent training and workshops surely help build expertise on the vendor side that is imparted by MAH.
Written by:
Dr.Shraddha Bhange.
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