Summary
Date Posted: Wednesday, August 18, 2021 , Base Salary: Not Disclosed

JOB DETAILS:
About Us
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly based healthcare company, we are committed to using our reach and siz...

The main duties and responsibilities of the position are:
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

Education Requirement: No Requirements

Job Experience: No Requirements

Work Hours: 8

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Job application procedure
Interested and qualified? Go to https://www.myjobmag.co.ke/apply-now/314736  to apply

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