The Position

As a Quality Assurance Specialist, you will ensure that the NN Quality System as well as local regulations are always implemented in Middle Africa and maintained according to corporate guidelines and products and business processes meet NN and local quality standards. You will also follow-up and ensure closure of audit findings issued during HQ and local audits.

The responsibilities will also include

• Training and communicating the QMS throughout the local affiliate organization, and distributing Quality Docs (SOP) updates to affiliate employees and maintenance of Quality Docs List
• Tracking of local quality laws and requirements in the affiliate also assisting review of the list of NN Procedures, QA approval, uploading local procedures in Quality Docs (SOPs), making reviews and updates of local procedures in Quality Docs as applicable. Distributes Quality Docs (SOP) updates to affiliate employees and maintenance of Quality Docs (SOP) List.
• Act as the Local GxP records Manager in maintaining status for documents in Archiving system for the affiliate. Serve as the affiliate Change Request and Deviations Expert on NovoGlow, and be responsible for preparation of QMR input and minutes of meeting with identified action points.
• Serve as lead auditor responsible for local distributor audits. Track the local quality laws and external requirements in countries. Ensure the distribution of the updated procedures (SOPs) to distributors before effective date

Qualifications

• You hold a bachelor’s degree in Pharmacy, pharmaceutical related studies, or medical sciences with a minimum of 3-5 years working experience in the similar position. A Master’s degree is a plus. You have excellent command over both written and spoken English. Further sought-after skills are:
• You have an innovative mindset
• You are good at computer and IT skills
• You have a strategic mindset, and great planning and execution skills.
• You have strong communication skill and an ability to build and maintain strong working relationships with various stakeholders.
• You are driven, can take initiative, and are agile in actions and detail oriented

The Position

As a Pharmacovigilance Manager, you will be responsible for Pharmacovigilance activities in compliance with local and Novo Nordisk requirements across Middle Africa (49 countries). You will also act as an affiliate safety reporting responsible person. Besides you will be ensuring timely review, update, and reporting all cases of Customer complaints and Adverse Reactions. Also, you will maintain status of all related safety and pharmacovigilance reports and give assistance in safety reporting to the local Health authorities in Middle Africa as applicable and in follow up and coordination of journal screening for safety reports related to Novo Nordisk products. Moreover, it is expected to ensure that any request from the Health Authorities in Middle Africa for additional information deemed necessary for the evaluation of the risk-benefit ratio of a marketed product, is provided fully and promptly.

The Other Responsibilities Will Include.

• Providing training in pharmacovigilance requirements in Middle Africa and ensuring that all personnel in Middle Africa involved in pharmacovigilance activities should be aware of the principles of pharmacovigilance that affect them, and all personnel shall receive relevant PV training. Ensuring that a backup person(s) is appointed to carry out PV activities their duties during the absence of the QPPV
• Establishing and maintaining a system which ensures that information about all suspected adverse drug reactions/events (or spontaneous post-marketing events) which are reported to NN personnel are collected, collated and sent to GS for processing within the timelines
• Having oversight of the pharmacovigilance system in Middle Africa countries including quality management system. And preparing, reviewing, and implementing company SOPs for PV activities in Middle Africa countries
• Establishing and maintaining a system which ensures that information about all suspected adverse drug reactions/events (or spontaneous post-marketing events) which are reported to NN personnel is collected, collated and sent to GS for processing within the timelines. And submitting the relevant documents prepared by Global Safety in HQ to the Health authority in Kenya through established channels after evaluation as applicable and within applicable timelines:
• Collaborating with internal stakeholders, Logistic, Marketing, Legal, Sales, BA, etc. to coordinate PV activities and help the Manager to set up annual strategy for the region in respective area. And acting as a point of contact to the Health Authority on all matters relating to the product safety and quality of marketed products in Kenya including pharmacovigilance inspections.

Qualifications

You hold a bachelor’s degree in Pharmacy, pharmaceutical related studies, or biomedical sciences with a minimum of 5 years working experience in the similar position. A Master’s degree in PV, Patient Safety, Health systems management is a plus. You have excellent command over both written and spoken English. Further sought-after skills are:

• You have an innovative mindset as the position requires very fast adaptation to changes and innovations in the industry.
• You have a strategic mindset, and great planning and execution skills.
• You also have people management experience and a team-oriented personality and can lead without authority, share knowledge, and coach team members.
• You are good at computer and IT skills and a working knowledge of systems
• You are driven, can take initiative, and are agile in actions and detail oriented