- Well Established Pharmacovigilance/ Drug Safety & Medical Information center with a system in place to continuously monitor the adverse Events/other safety issues / Medical Information enquiries of a Drug and thus promote safer use of medicines’ includes delegate Qualified Person for Pharmacovigilance, Deputy Qualified Person for PV & PV Surveillance co-coordinator
- Process spontaneous and solicited adverse events reports/Medical Information enquiries from the country/territories and forward to a designated contractual partners. Simultaneously recording & maintaining the data.
- Conduct reconciliation of adverse events reports/ Medical Information enquiries received from other company and contractual partners, as applicable
- Submit, as applicable, spontaneous and solicited / individual case safety reports (ICSRs) from their country to contractual partners & if applicable to the local Health Authorities
- File, store, and archive all safety-related data
- Prepare for audits/inspections for their contractual partners
- Identify and communicate all potential safety issues
- Deliver training to PV & MI (Medical information) staff and also to the other employees of the company
- Train and mentor PV & MI (Medical information) staff
- Complete and document required PV & MI (Medical information Centre) training within required timelines
- Serve as the point of contact for the local Health Authority or liaise with the contractual partners