Job Description
The PV Case Processing Officer handles responsability for the management of pharmacovigilance cases subcontracted to a vendor from collection to submission
Pharmacovigilance Case Processing Officer
Activities & Responsibilities
The Pharmacovigilance Case Processing Officer is responsible for :
Monitoring the activities outsourced to the service providers : Management of pre and post-marketing pharmacovigilance cases in line with the Case Management team and Service provider : book-in, data entry, documentation, coding, narratives, evaluation, quality control, medical review and submission of the cases to ensure compliance with regulatory requirements, with Safety Data Exchange Agreements and procedures in place
Management of cosmetovigilance cases
Litterature surveillance process
Reconciliation with business partners, LPVs and clinical databases. Performing a weekly quality control of cases processed by the ve...