Pharmacovigilance Case Processing Officer
Il y a 2 mois
The PV Case Processing Officer handles responsability for the management of pharmacovigilance cases subcontracted to a vendor from collection to submission.
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 vendor. Reviewing legal cases with B/R unit representative. Drafting/Validating the deviation forms (root cause, CAPA) for cases submitted late to Regulatory authorities. Reviewing the protocol, the eCRF and writing the Safety Management Plan for clinical trials. Providing necessary documents and training to the vendor so that he has adequate information to perform the outsourced activities. Requesting the update of ARGUS database configuration for studies, products, reporting rules, Reference Safety Information.
S/He participates to:
S/He contributes to:
Profile
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