Company Description
Union Healthcare Partners, founded in 1946, is a leading promoter and distributor of pharmaceuticals and hospital supplies, representing major multinational and local companies. The organization is committed to being a reliable and trusted partner through a strong focus on operational excellence, compliance, and quality. Union Healthcare operates across the healthcare spectrum through dedicated divisions for Pharmaceuticals, Hospital Supplies, Dental Care, Animal Health, OTC, and Merchandising. This broad portfolio enables the company to support diverse healthcare needs and collaborate with a wide range of stakeholders.
Role Description
We are looking for a Senior Pharmacovigilance (PV) Specialist to maintain and continuously strengthen our pharmacovigilance system and ensure compliance with applicable regulatory requirements. You will be the primary point of contact with the Ministry of Health (MoH) and our suppliers on safety matters, ensuring adverse events and safety data are collected, assessed, reconciled and reported on time. You will also oversee MoH PV submissions and support audit readiness, quality processes and PV training across the company.
Main Responsibilties
- Act as the PV point of contact for the MoH and suppliers.
- Maintain up-to-date PV systems and databases, documenting all safety data according to company and regulatory guidelines.
- Coordinate and oversee the collection, assessment and reporting of adverse drug reactions (ADRs), adverse events (AEs) and other PV issues from the local market.
- Perform monthly and quarterly reconciliations, and follow up on literature screening.
- Complete and submit PV questionnaires for internal and external purposes.
- Ensure the 24-hour PV coverage system is in place.
- Review and assess PV agreements, and review and update SOPs as needed.
- Submit ICSRs, PSURs/PBRERs and RMPs according to local regulations and supplier recommendations, and support the monitoring and reporting of Post-Authorization Safety Studies (PASS).
- Maintain, review and update the Pharmacovigilance System Master File (PSMF).
- Coordinate the implementation and review of Risk Management Plans (RMPs) and risk minimization measures, and communicate safety information to stakeholders and healthcare professionals.
- Maintain and improve the PV quality system, including deviations, changes and CAPAs.
- Support PV audits, handle MoH PV inspections, and develop CAPA plans for any findings.
- Conduct equipment testing and PV business continuity plan (BCP) testing.
- Deliver all internal PV training and attend PV training sessions.
Qualifications
- Bachelor’s or advanced degree in Pharmacy, or Pharmacology.
- At least 3 to 4 years of experience in pharmacovigilance.
- Strong knowledge of pharmacovigilance guidelines, safety databases, and standard reporting tools.
- Strong analytical skills, attention to detail, and ability to manage multiple safety cases and projects.
- Effective written and verbal communication skills, including the ability to prepare clear regulatory reports.
- Ability to collaborate with cross-functional teams and work within structured quality and compliance frameworks.
- Fluency in English; proficiency in Arabic or French is an asset.
