Career Opportunity: Regulatory Quality and Pharmacovigilance Coordinator – Middle Africa
Novo Nordisk is looking for a motivated and well-rounded person to take up the role of Regulatory (RA), Quality (QA) and Pharmacovigilance (PV) Coordinator for Middle Africa (MA) on Contract basis renewable annually based on performance.
This person will Coordinate and support the implementation of RA, QA and PV strategy and drive activities across Middle Africa in compliance with Novo Nordisk and External requirements and will be based out of Nairobi, Kenya.
Novo Nordisk Middle Africa Affiliate
The Novo Nordisk Middle Africa Affiliate consists of 49 countries and was formed early in 2012. Novo Nordisk has a well-established presence in Africa with the best quality human insulin and our focus today is to sustain the growth of the market, ensure access to better quality modern insulin and newer product formulations and support people living with diabetes.
The Job:
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.
How to Apply:
Kindly send your CV to recruitment@sheerlogicltd.com by 8th June 2022 clearly marking – “Regulatory Quality and Pharmacovigilance Coordinator Middle Africa” as subject head.