Pharmacovigilance Specialist

7 days ago

Qesm st Nasser City Cairo, Egypt Al-Esraa Pharmaceutical Optima Full time 40,000 - 60,000 per year

Company Description

Al-Esraa Pharmaceutical Optima, a division of Al-Esraa Corporation, has been a trusted pharmaceutical manufacturer since 1998, serving the health needs of the Middle East. The company specializes in producing a wide range of products, including prescription drugs, vitamins, cosmetics, and herbal OTC products, all while prioritizing customer demands. Al-Esraa operates state-of-the-art manufacturing facilities equipped with modern production technology and four production lines, ensuring high-quality products and large-scale capacity. With an experienced team of over 200 health professionals, the company is committed to delivering reliable and efficient services to its partners and clients.

Role Description

We're seeking a dedicated and detail-oriented Pharmacovigilance Specialist to join our team and support the Qualified Person for Pharmacovigilance (QPPV) in maintaining and enhancing our pharmacovigilance system.

If you're passionate about patient safety, regulatory compliance, and continuous learning, this role is for you

Key Responsibilities

  • Support the QPPV in managing an effective pharmacovigilance (PV) system that ensures prompt detection, evaluation, and reporting of adverse events and safety concerns.
  • Conduct literature searches and reviews to maintain up-to-date safety information.
  • Prepare and submit adverse event and ADR reports to regulatory authorities within required timelines.
  • Maintain accurate and organized documentation for all PV cases and activities.
  • Draft, review, and update PV Standard Operating Procedures (SOPs).
  • Participate in the preparation of PSURs, PBRERs, RMPs, and ACOs.
  • Monitor regulatory changes and ensure alignment with updated PV guidelines.
  • Contribute to the development and delivery of pharmacovigilance training programs.
  • Support CAPA activities and act on behalf of the QPPV when delegated.

Qualifications

  • Knowledge of Regulatory Requirements and experience in Regulatory Affairs
  • Strong understanding of Pharmacy and Medicine
  • Familiarity with Clinical Trials and related processes
  • Keen attention to detail and strong analytical skills
  • Ability to interpret and apply complex regulations in pharmacovigilance
  • Proficiency in communication and documentation
  • Bachelor's Degree in Pharmacy (Pharmacovigilance certification required)
  • 2–3 years in Pharmacovigilance
    in the pharmaceutical or healthcare industry is a plus

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