Что такое the expectedness call? Ожидаемое посещение?

И в целом, кто - нибудь знает, где можно найти русский перевод целого PSUR для примера?

PHARMACOVIGILANCE OFFICER (PHOF)

Client: A leader company in the health sector, with international presence. With a qualified team of people and the relevant know-how is considered to be the expert in its field and an employer of choice.

Τhe job holders will belong to the Regulatory Affairs Department and will be responsible for the management of pharmacovigilance affairs.

More specifically, the job responsibilities will be as follows:
- Supports the dept on communicating pharmacovigilance issues between all relevant parts.
- Operates in compliance company’s applicable protocols as well as with the national and international regulatory reporting requirements relating to Adverse Event (AE).
- Collects, analyses, evaluates seriousness, conducts follow-up calls, documents and archives AE reports on marketed human products, handled by the company.
- Performs the expectedness call, by assessing AE reports against applicable label.

For purposes of periodic safety reporting, CCSI forms the basis for determining whether an adverse drug reaction is already LISTED or is still UNLISTED, terms which are introduced to distinguish them from the usual terminology of "expectedness" or "labeledness" which is used in association with official labeling. Thus, the local approved product information continues to be the reference document upon which labeledness/expectedness is based for the purpose of local expedited post-marketing safety reporting.