Duration:
3-4 months (part-time 20 hours per week)
Description:
The client is in need of a pharmacovigilance SME consultant to help define the process for creating and maintaining the CCDS/CCSI (company core data sheet / company core safety information) for a couple of new products which previously have only been approved in the U.S. market. The products are orphan drugs and are a therapeutic used for treating diseases of the blood (hemophilia, etc.) that are protein based isolated/purified from blood plasma. The first step would be to help define the process/procedures (~ 1 week +/-) and then help to draft the CCDS/CCSI’s. The CCDS and CCSI will need to contain all the data evaluation material for the medicinal product, the safety information, the material related to indications, dosing, pharmacology and other information concerning the product and contain reference information for periodic reporting. The consultant will need to have previous demonstrated experience creating procedures/processes as well as drafting CCDS/CCSI
Remote: Pharmacovigilance SME (235760)
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