A reputable distributor company in Dubai is hiring an experienced Senior Pharmacovigilance (PV) Specialist to establish and update the Pharmacovigilance system, ensure compliance with local PV guidelines, and support MOH reporting. The role requires strong regulatory expertise, documentation skills, and the ability to collaborate with principal companies and authorities.
Key Responsibilities:
– Establish and update Pharmacovigilance systems.
– Review & approve Safety Data Exchange Agreements (SDEA).
– Ensure proper submission of local adverse event reports (serious/non-serious) to MOH.
– Maintain a reconciliation system to track case reports and quarterly reviews.
– Conduct PV refreshment training for internal teams.
– Archive PV records securely and maintain regulatory documentation.
– Prepare for and attend PV audits.
– Submit Periodic Safety Update Reports (PSURs) to MOH.
– Monitor new PV guidelines, ensuring regulatory intelligence updates.
– Represent the company in MOH and other regulatory authorities.
– Handle local PV officer appointment submissions and approvals.
– Author SOPs and contribute to PSMF/PSSF documentation.
Qualifications:
✔️ Bachelor’s degree in Pharmacy (mandatory).
✔️ 2-5 years of experience in a similar Pharmacovigilance role.
✔️ UAE market knowledge is preferred.
✔️ Strong product knowledge.
✔️ Regulatory experience is a plus.
✔️ Proficiency in PV-related computer systems.
✔️ Certifications in Pharmacovigilance are advantageous.