Patient Safety Manager
3 days ago
**ABOUT ASTRAZENECA**
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.
**Role Summary**:
The Patient Safety Manager is responsible for the implementation of Pharmacovigilance legislation set by the Egyptian Drug Authority in Egypt in terms of reporting, submitting & following up on different safety reports related to marketed products.
The Patient Safety Manager will provide assurance of quality and compliance across key pharmacovigilance processes & ensure Egyptian Drug Authority requirements related to different pharmacovigilance activities are met on time.
**What you’ll do**:
- Ensure the compliance of submission of ICSRs to the Egyptian Drug Authority (EDA) in Egypt according to local regulatory timelines.
- Act as QPPV in EDA for AstraZeneca Registered products in Egypt.
- Develop a comprehensive local Patient safety plan for different Pharmacovigilance activities in Egypt.
- Act as the main contact point for pharmacovigilance inspection or audits & lead the local market activities to fill the identified gaps.
- Develop & maintain the updates of local Patient safety SOPs/ PSMF.
- Identify Patient safety quality issues, and risks & set CAPA & mitigation plans accordingly.
- Ensure Local Pharmacovigilance processes are in place for recording, processing, and following up on spontaneous and solicited adverse event reports.
- Ensure reporting PV incidence related to pregnancy, overdose, lack of effect, medication errors misuse, and abuse whether or not associated with AEs or product quality complaints (PQC), where applicable.
- Ensure reporting of Serious Adverse Events (SAE)s from local interventional clinical studies, and local non-interventional studies within the defined timelines, where applicable
- Monthly quality checks on the Pharmacovigilance system & updated PV records.
- Monitor Compliance with internal Pharmacovigilance procedures and regulatory Authorities’ guidelines.
- Develop a reconciliation process to track all Adverse events received from Medical Information teams, local distributors, or third parties running patient support programs / Market research.
- Ensure reporting PSUR/PBRER/RMP/Signals to regulatory authorities on time.
- Ensure delivery of patient safety training to all AZ staff & third parties engaged with both HCP & AstraZeneca.
- Respond to MOH requests related to the safety of AstraZeneca’s Products
- Timely submission of Direct Healthcare Professional Communications (DHPC).
- Monitoring of insights gathered by the medical team in Egypt against any Adverse event.
- Report Counterfeit or any suspected samples to global product security departments.
- Monitoring & Review the Recall process of any of AZ products, where applicable
- Ensure the implementation of Quality elements within the Pharmacovigilance quality area.
**Essential for the role**:
- Holding a bachelor’s degree in pharmaceutical science / Medicine or Equivalent
- Excellent Knowledge of the Pharmacovigilance system in Egypt & health authorities’ requirements on Pharmacovigilance activities.
- Proven leadership and project management experience record.
- Knowledgeable of the Egyptian healthcare environment/systems.
- Medical integrity and ethical balance.
- Languages: Fluent in English.
**Desirable for the role**:
- Qualification/certification in Pharmacovigilance & Patient Safety.
- Two years’ experience in Pharmacovigilance management in a multinational pharmaceutical company.
- Working Experience with a health authority / regulatory body in Egypt.
**Why AstraZeneca?**
At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference in medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and is always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.
**So, what’s next?**
- Are you already imagining yourself joining the global Patient safety team? Good, because we can’t wait to hear from you.
- Are you ready to bring new ideas and fresh thinking to the table? Brilliant We have one seat available, and we hope it’s yours.
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