What post-market safety responsibilities should be agreed before launch?

Define how adverse events, lack of expected effectiveness, product defects, human exposure and potential residue issues will be captured, assessed, escalated and reported. The marketing authorisation holder and local partners may have time-bound pharmacovigilance obligations. Contracts should establish contact points, weekend coverage, data fields, translation, record retention and reconciliation. Complaint handling and pharmacovigilance are connected but not identical, so both workflows need owners.