PV Associate, LSR Egypt

Cairo, Egypt, Middle East, Turkey, and Africa

Acino is a Swiss pharmaceutical company, leader in advanced drug delivery technologies. We have a clear focus on selected emerging markets in the Middle East, Africa, the CIS Region and Latin America, and operate in some of the most dynamic countries of the world.  We value courage, commitment, trust and empathy and provide an environment that supports initiative and effort. We are proud to be action-oriented and open-minded, with a strong focus on quality and product availability, even in remote and hard to reach areas of the world.

This position is based in Cairo, Egypt and will report directly to the Country Head, Egypt. The role will be responsible for maintaining the updates of the PV Quality Management System in addition to acting as Local Safety Responsible (LSR) for Acino Egypt.

Your Responsibilities will be :

• Establish and maintain the local PV Quality Management System (QMS) including master documents, PSSF, SOPs etc and submission of all pharmacovigilance-related documents in accordance with the national legal requirements and GVP in Egypt
• Perform annual PV awareness training for Acino Egypt personnel and newcomers including the deputy per MAH’s procedures
• Keep up-to-date with the relevant regulations and guidelines (PV Intelligence)
• Prepare and distribute the submission plan of PSURs, RMPs, DHCPs and PSMF/PSSFs and follow-up on the implementation of RMMS in Egypt, when applicable
• Represent Acino office in Egypt and the MAH in all safety related activities
• Act as single point of PV contact for distributors, EPVC and as a contact point for PV inspections
• Keep oversight over the functioning of the PV system and implementation of standard procedural documents and processes in Egypt
• Work closely and in collaboration with Regional PV Manager META, Global PV and external service providers
• Have an overview of medicinal product safety profiles and any emerging safety concerns
• Provide input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals)
• Perform and document PV due diligence on distributors and service providers according to internal process
• Create and approve Safety Data Exchange Agreements (SDEAs) with service providers, distributors, CMOs and other business partners and monitor their performance and compliance accordingly
• Schedule and participate in internal and external audits of distributors and contract manufacturers Adhere to Acino internal policies and standard operating procedures designed to ensure patient safety, including mandatory attendance at pharmacovigilance training
• Forward all received Product Quality Complaints, Adverse Events and Medical Information
• Requests to the relevant person in Quality Assurance/Pharmacovigilance/Medical Affairs

Your Profile :

• Bachelor’s degree in Pharmacy
• Minimum of 3 years professional experience in PV in pharmaceutical industry and at least 1 year experience as QPPV/LSR Egypt
• Excellent command of written and spoken English language
• Ability to maintain a structured documentation and archiving system
• Excellent working knowledge of MS Office (Outlook, Word, Excel, PowerPoint)
• Must be able to multi-task in a fast-paced environment
• Excellent communication skills, demonstrates success in building productive relationships with all stakeholders
• Attention to details and accuracy
• High level of intellectual curiosity, self-motivated to solve difficult issues, continually seeking ways to improve

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!.

Please note only direct applications via our HR system will be considered.