About this role
ROPU IMETA is a Regional Operating Unit consisting of 6 mid-sized Operating Units: India, Near East & UAE, Saudi Arabia, Gulf & East Africa (SAGEA), Türkiye, North East & West Africa, Southern Africa (South Africa & Sub Saharan Africa). Our strength lies in our exceptional talent and shared commitment to growing, developing, and retaining our people. Together, we collaborate to drive success and create lasting impact.
The Opportunity
We are hiring a Local Patient Safety Lead based in Cairo, Egypt. The person responsible will lead the North East & West Africa Patient Safety & Pharmacovigilance function, driving local PV strategy, regulatory compliance, patient safety oversight, and continuous patient-focused improvements while serving as the Local QPPV and Health Authority contact.
The job holder will report to the Medical Director.
Responsibilities:
- Lead and develop the Patient Safety & Pharmacovigilance (PSPV) team and define the local PSPV strategy based on the framework provided by global PSPV.
- Ensures the establishment and maintenance of a local pharmacovigilance (PV) system to safeguard patient's and clinical trial subject’s safety and public health in compliance with regulatory requirements and applicable internal procedures and processes.
- Ensures compliance with external requirements in line with the local PV legislation and applicable internal procedures and processes allowing the company to obtain and maintain marketing authorization of its products.
- Acts as local PV contact person/Local QPPV for the national Health Authority as legally required.
- Initiates, evaluates, implements and supports activities that are patient oriented and improve the status quo.
Requirements:
- Bachelor’s degree in Pharmacy
- 3 to 5 years of Patient Safety and Pharmacovigilance experience
- Experience in the Egypt and North Africa countries
- Knowledge of Boehringer Ingelheim’s therapeutic areas is a plus
Skills/Competencies
- Strong functional and technical expertise in Pharmacovigilance, including safety database management
- Excellent knowledge of applicable global, regional and local Pharmacovigilance regulations, relevant GxP requirements and patient safety relevant topics
- Proven experience with health authority interactions, inspections, audits, CAPA management, and inspection readiness
- Experience managing license partners, third-party vendors, and PV agreements (PVAs)
- Excellent leadership skills to manage a diverse team
What’s Next?
We are looking forward to receiving your application! We will then have a look at your profile. If we see a match, we will invite you for a screening interview.
Screening:
To comply with applicable export control laws, Boehringer Ingelheim periodically screens business relations (including job applicants) against sanctioned party lists (“SPL”). These checks may be performed by Boehringer Ingelheim or by any of its Affiliates. You acknowledge that Boehringer Ingelheim and/or its Affiliates will screen you against SPL and that for this purpose your personal data may be processed in relevant databases, including databases of third-party vendors that perform SPL screening for or on behalf of Boehringer Ingelheim or its Affiliates which may be located or accessible outside the EU. Boehringer Ingelheim is committed to ensuring an adequate level of protection of your personal data.