Pharmatrade is looking for a Local Safety Responsible (LSR) to support our Pharmacovigilance operations in the UAE. This role will report to the Head of Regulatory Affairs & Pharmacovigilance and will work closely with principal companies and internal stakeholders to ensure robust compliance, timely case management, and inspection readiness.
Key Responsibilities
- Support implementation and maintenance of the local PV system and PV SOPs.
- Manage local safety data collection from all sources (sales/marketing, medical information, partners, HCPs/patients), including logging, completeness checks, and follow-up coordination.
- Manage ICSR exchange in line with UAE PV requirements and SDEA/PVA obligations.
- Ensure timely submissions and responses via the EDE/MOHAP portal, including handling authority queries and maintaining audit-ready records.
- Coordinate and document reconciliations with principals and internal functions, including discrepancy closure.
- Maintain PV records in a secure and inspection-ready manner (case files, reconciliations, training, correspondence, agreements, submissions).
- Coordinate PV training/refreshers for relevant staff and maintain training evidence.
- Monitor local PV updates/circulars and support implementation of required actions.
- Support PV audits/inspections and CAPA follow-up under the supervision of the Head of RA & PV.
Qualifications
- Bachelor's Degree in Pharmacy (mandatory).
- 24 years of hands-on experience in Pharmacovigilance.
- Familiarity with UAE PV requirements.
- Experience working with SDEA/PVA obligations and partner communication.
- Strong documentation skills, attention to detail, and ability to work under timelines.
Preferred
- Exposure to PSMF / national PVSF concepts and audit readiness practices.
- Interacting with Health Authority portals is a strong advantage.
