Regulatory Quality and Pharmacovigilance Coordinator job at Novo Nordisk
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Vacancy title:
Regulatory Quality and Pharmacovigilance Coordinator

[ Type: FULL TIME , Industry: Pharmaceutical , Category: Healthcare ]

Jobs at:

Novo Nordisk

Deadline of this Job:
08 June 2022  

Duty Station:
Within Kenya , Nairobi , East Africa

Summary
Date Posted: Thursday, June 02, 2022 , Base Salary: Not Disclosed

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JOB DETAILS:
Responsibilities
The RA, QA and PV Coordinator will be responsible for the following:
• Coordinate the printing and dispatch of Regulatory documents to the RA agents in Middle Africa
• Provide support with ordering valid RA documents required by tenders’ team (CPPs, GMPs) for the whole of Middle Africa and plan accordingly for those almost expiring. Keep a database for the same.
• Maintain database of RA agent contracts and Safety Data Exchange Agreements and keep track of payments to be made to the agents according to applications completed as per contracts.
• Assist with Minutes in Monthly RA, QA, PV and Logistics meetings.
• Clean-up of RA, QA and PV shared folders and archiving as per document retention policy and capturing all documents in the Wells Fargo Archive and local archive in the indexing tool.
• Coordinate the QC checks on customer contact logging, customer complaints, literature reviews and IO engage.
• Send the monthly reconciliation emails to SDEA partners (including encryption testing)
• Perform a review of HALO PV and ensure all requirements s are captured in the system.
• Come up with a campaign(s) to raise PV/QA awareness in the affiliate including PV safety day and QA day.
• Maintaining the Deviation & Change Request overview and keeping track of the timelines.
• Establish a Distributors Training plan and assist with the rollout of the new training platform.
• Assist in follow-up of SOP training Logs
• Assist in maintaining the overview of product release and keep track of destruction certificates.
• Assist in follow-up and archiving of the Biannual external requirements request/reconciliation from the distributors.

Qualifications
To qualify for the position, you must have:
• Bachelor’s degree preferably in Pharmacy or other related Pharmaceutical Sciences.
• An innovating mindset in a changing environment as the position requires very fast adaptation to changes and innovations in the industry.
• Problem solving and analytical skills and be capable of working in a culture of respect, teamwork and personal responsibility.
• Fluency in written and spoken English.

Job Experience: No Requirements

Work Hours: 8


Level of Education:
Bachelor Degree

Job application procedure
Kindly send your CV to recruitment@sheerlogicltd.com by 8th June 2022 clearly marking – “Regulatory Quality and Pharmacovigilance Coordinator Middle Africa” as subject head.

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Job Info
Job Category: Health/ Medicine jobs in Kenya
Job Type: Full-time
Deadline of this Job: 08 June 2022
Duty Station: Kenya
Posted: 02-06-2022
No of Jobs: 1
Start Publishing: 02-06-2022
Stop Publishing (Put date of 2030): 02-06-2065
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