Pharmacovigilance Vacancy At Novo Nordisk Egypt
Title:Senior Pharmacovigilance Associate
Category: Reg Affairs & Safety Pharmacovigilance
Location: Cairo, EG
Are you passionate about ensuring patient safety? Do you have experience in pharmacovigilance and risk management? We are looking for a dedicated Senior Pharmacovigilance Associate to join our team in Egypt. If you are ready to make a difference in the field of drug safety, read on and apply today for a life-changing career.
The Position
As a Senior Pharmacovigilance Associate, you will be maintaining and continuously improving the affiliate Pharmacovigilance and Device Vigilance systems in Egypt. You will participate in external audits and following up on CAPAs timely completion. In addition, you will be acting as contact point for pharmacovigilance audits and inspections and for the local health authorities on a 24-hour basis.
Your main responsibilities will be:
• Monitoring the safety profiles of our marketed products and addressing any emerging safety concerns and submitting PV New Drug/Device Application file, PV Renewal file, PSUR, RMP, ACO, SMH and any other Pharmacovigilance & Device Vigilance related files to LHA.
• Conducting pharmacovigilance training for internal employees and external partners and onboarding new employees at safety department, and communicating Safety requirements to business partners and assisting them in their implementation
• Handling pharmacovigilance cases, customer complaints, and adverse events for marketed products, and ensuring the overall compliance of PV activities to the local and global regulations as applicable.
• Ensuring compliance with local and global regulations related to pharmacovigilance activities, and safety reporting for clinical trials.
• Collaborating with the Regulatory & Safety team at our headquarters and leading the implementation of Global Safety pharmacovigilance projects in NN Egypt
Qualifications
You hold a bachelor’s degree in pharmacy and you are a certified QPPV to work with the Egyptian Drug Authority within 3-5 years of experience in pharmacovigilance and risk management. You are fluent in both written and spoken Arabic and English. Having a multinational organization experience and/or Postgraduate studies would consider a plus.
Further sought-after skills are:
• You are familiar with regulatory guidelines and requirements related to drug safety.
• You have good understanding of regulations set forth by health authorities
• You have strong knowledge of local and global regulations related to Pharmacovigilance
• You have the business and industry understanding
• You can communicate with different kinds of stakeholders
As a person you are a high performing, customer centric team player, have the ability to focus on priorities.
About The Department
The Pharmacovigilance department in Novo Nordisk Egypt is responsible for ensuring the safety of our products and maintaining compliance with regulatory requirements. We work closely with local health authorities and internal stakeholders such as regulatory, commercial, and medical teams to detect, assess, understand, and communicate safety information. Our team is dedicated to patient safety and strives to make a positive impact on the healthcare industry in Egypt.
Deadline
Apply before 5 July 2024