Pharmacovigilance Specialist - UAE (QPPV Ready)

Novo Nordisk A/S

Dubai

On-site

AED 180,000 - 270,000

Full time

4 days ago
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Job summary

Novo Nordisk A/S in Dubai seeks a Pharmacovigilance Specialist to ensure safety information about Novo products is collected, assessed and reported in line with local and global regulatory requirements, directly protecting patients.

You will act as the QPPV for UAE, maintain the PV system, oversee ADR reporting, deliver PV onboarding training, manage safety data exchanges and ensure PSURs and RMPs are submitted on time.

Qualifications

  • Minimum of 3 years of experience in Pharmacovigilance.
  • Fluency in written and spoken English and Arabic.
  • Knowledge of local/global pharmacovigilance regulations.
  • Sound understanding of PV Agreement lifecycles.
  • High level of computer literacy, including MS Office.

Responsibilities

  • Acting as the QPPV for Novo products in UAE.
  • Maintenance of the PV system within the affiliate in accordance with internal SOPs and local regulations.
  • Reporting of ADRs to Global Safety & UAE EDE within set timelines.
  • Handling technical complaints.
  • Periodic PV onboarding training to external vendors (PSPs and MRPs).
  • Managing Safety Data exchange Agreements with partners.
  • Timely submission of PSURs and RMPs to local authority.
  • Daily check and review of the local PV Safety Mailbox.
  • Local requirements process is executed timely and effectively.

Skills

QPPV UAE
ADR reporting
PV system maintenance
Training delivery
Safety data exchange
PSUR & RMP knowledge
MS Office
Stakeholder management
English & Arabic

Tools

MS Office

Job description

Novo Nordisk A/S in Dubai seeks a Pharmacovigilance Specialist to ensure safety information about Novo products is collected, assessed and reported in line with local and global regulatory requirements, directly protecting patients.

You will act as the QPPV for UAE, maintain the PV system, oversee ADR reporting, deliver PV onboarding training, manage safety data exchanges and ensure PSURs and RMPs are submitted on time.

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