Pharmacovigilance Vacancy At Marcyrl Pharmaceutical
Position: Pharmacovigilance Specialist
Marcyrl Pharmaceutical Industries is one of Egypt’s leading pharmaceutical companies, committed to improving the health and well-being of people through high-quality, affordable medicines. Established in 1998, Marcyrl has grown steadily to become a trusted name in the pharmaceutical industry, with a strong presence in the Egyptian market and an expanding regional reach.
Job Brief:
Carrying out responsibilities delegated by the QPPV and sharing responsibilities regarding follow-up with the PVGA and the safety newsletters concerning the safety updates of the active constituents of our local products.
Key Responsibilities:
• Manage day-to-day Pharmacovigilance (PV) activities in compliance with local regulations and Good Pharmacovigilance Practice (GVP).
• Collect, assess, process, and submit Individual Case Safety Reports (ICSRs), including case validation, seriousness, causality, follow-up, and reporting.
• Prepare and submit Pharmacovigilance documents, including PBRERs, RMPs, ACOs, CIOMS reports, signal notifications, DHPCs, and other required safety reports.
• Monitor regulatory requirements, safety updates, EURD lists, EDA communications, and PVGA announcements to ensure timely compliance.
• Support the maintenance of the Pharmacovigilance System Master File (PSMF), SOPs, and product safety documentation.
• Maintain and update product safety information and PV-related records, ensuring accurate documentation and archiving.
• Track and respond to PVGA requests, comments, and regulatory submissions within the required timelines.
• Monitor product safety profiles, emerging safety concerns, and risk minimization activities.
• Support internal and external audits and regulatory inspections by providing the required documentation and ensuring PV compliance.
• Collaborate with Regulatory Affairs, Quality, Medical Affairs, and other cross-functional teams on pharmacovigilance activities.
• Ensure the quality, accuracy, and completeness of all pharmacovigilance data submitted to health authorities.
• Deliver pharmacovigilance awareness and ADR reporting training to company employees as required.
Job Requirements:
• Bachelor's degree in Pharmacy or Bachelor's degree in Medicine.
• 0–1 years of experience in the Pharmacovigilance field.
• Fluent in written and spoken English.
How to Apply:
If you're passionate about communication and people, and eager to contribute to a leading pharmaceutical company, send your CV to jobs@marcyrlgp.com.
"Please mention the job title and area in the email subject line."