The Responsibilities & The Impact YOU Will Have
The main duties and responsibilities of the position are:
SAFETY MANAGEMENT & REPORTING
Case Processing
Ensure that systems and processes are available for collection (initial and follow up), review, reporting and reconciliation of Adverse Events (AEs), Adverse Events combined with Product Quality Complaints (AE+PQCs) and pregnancy reports obtained through the following sources: spontaneous, solicited, clinical trials, data generating activities, local Regulatory Authorities (RAs) and all other potential sources.
Manage and maintain active involvement in day-to-day AE reporting as applicable. (case registry, compliance with global organization requirements)
Accountable internally for ensuring that the LOC meets procedurally defined timelines for management of safety information and any local regulatory agency defined timeline for submission of individual reports.
Translation
Translation of ICSR, PSUR, HA correspondence, regulatory intelligence, as required.
Oversight And Providing Input
Oversight of data generating activities to ensure any solicitation for information includes an appropriate review and reporting process for reporting potential AEs (e.g. patient support programs, market research surveys, internet sites), as applicable.
Assure all vendor contracts have appropriate Pharmacovigilance language incorporated and that these contracts are archived in the global system, as applicable.
Safety oversight of clinical projects conducted in the territory as applicable.
Clinical Trial Compliance
Collaboration with Medical Affairs for the review and approval of safety aspects of local study protocols or Patient Support Programs (PSP) to ensure appropriate safety reporting to GMS or appropriate case management centre and RA, as required
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